#fda-approval

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#zepbound

F.D.A. Approves Weight-Loss Drug to Treat Sleep Apnea

Zepbound is the first ever FDA-approved medication for treating obstructive sleep apnea, particularly aimed at those with obesity.

The First Sleep Apnea Drug Is Here

Zepbound gains FDA approval for treating obstructive sleep apnea, marking a breakthrough in weight-loss medication benefits.

Weight loss drug Zepbound may help people with obstructive sleep apnea, drugmaker says

Zepbound, a weight loss drug, shows potential in treating obstructive sleep apnea, with trial results prompting Eli Lilly to seek FDA approval for expanded use.

F.D.A. Approves Weight-Loss Drug to Treat Sleep Apnea

Zepbound is the first ever FDA-approved medication for treating obstructive sleep apnea, particularly aimed at those with obesity.

The First Sleep Apnea Drug Is Here

Zepbound gains FDA approval for treating obstructive sleep apnea, marking a breakthrough in weight-loss medication benefits.

Weight loss drug Zepbound may help people with obstructive sleep apnea, drugmaker says

Zepbound, a weight loss drug, shows potential in treating obstructive sleep apnea, with trial results prompting Eli Lilly to seek FDA approval for expanded use.
morezepbound
#cosmetic-surgery

Exclusive | I got the newest, trendiest breast implants - everyone in NYC wants a pair

Dayanara Perez loves her new Motiva breast implants for their natural look and feel, appreciating advancements in cosmetic surgery.
The FDA approved Motiva implants, designed to enhance women's health while providing a natural aesthetic.

A woman paid $12,000 for surgery to permanently turn her eyes from brown to blue. She said it's the best investment she's made in herself.

Ulku Dogan underwent keratopigmentation surgery to permanently change her eye color, expressing satisfaction and confidence with the result.

Exclusive | I got the newest, trendiest breast implants - everyone in NYC wants a pair

Dayanara Perez loves her new Motiva breast implants for their natural look and feel, appreciating advancements in cosmetic surgery.
The FDA approved Motiva implants, designed to enhance women's health while providing a natural aesthetic.

A woman paid $12,000 for surgery to permanently turn her eyes from brown to blue. She said it's the best investment she's made in herself.

Ulku Dogan underwent keratopigmentation surgery to permanently change her eye color, expressing satisfaction and confidence with the result.
morecosmetic-surgery
#public-health

No needles required: The FDA approves an at-home flu vaccine

Self-administered FluMist nasal spray enhances access to flu vaccination and encourages more people to get vaccinated.
FDA's approval demonstrates commitment to advancing public health and reducing barriers to vaccination.

FDA approves updated COVID-19 vaccines; shots should be available in days

Updated COVID-19 vaccines have been approved and are set to be shipped, targeting recent virus strains for better protection this winter.

FDA approves updated COVID-19 vaccines

Updated COVID-19 vaccines approved to target recent variants, encouraging eligible individuals to enhance their protection as winter approaches.

FDA OK's new COVID vaccine shots for fall 2024 from Pfizer and Moderna

The FDA has approved updated COVID-19 vaccines for the 2024 fall season, targeting the KP.2 variant.
Vaccination campaigns are encouraged for broader population immunity against circulating variants.

New Covid Vaccines Are Coming. Here's What to Know.

Updated Covid-19 vaccines targeting the KP.2 strain have been approved and are recommended for all individuals six months and older.

Nasal Flu Vaccine Is Approved for At-Home Use

FluMist is now authorized for at-home use, providing a needle-free flu vaccination option that increases accessibility.
The approval introduces a new alternative to traditional flu shots, particularly for children and those afraid of needles.

No needles required: The FDA approves an at-home flu vaccine

Self-administered FluMist nasal spray enhances access to flu vaccination and encourages more people to get vaccinated.
FDA's approval demonstrates commitment to advancing public health and reducing barriers to vaccination.

FDA approves updated COVID-19 vaccines; shots should be available in days

Updated COVID-19 vaccines have been approved and are set to be shipped, targeting recent virus strains for better protection this winter.

FDA approves updated COVID-19 vaccines

Updated COVID-19 vaccines approved to target recent variants, encouraging eligible individuals to enhance their protection as winter approaches.

FDA OK's new COVID vaccine shots for fall 2024 from Pfizer and Moderna

The FDA has approved updated COVID-19 vaccines for the 2024 fall season, targeting the KP.2 variant.
Vaccination campaigns are encouraged for broader population immunity against circulating variants.

New Covid Vaccines Are Coming. Here's What to Know.

Updated Covid-19 vaccines targeting the KP.2 strain have been approved and are recommended for all individuals six months and older.

Nasal Flu Vaccine Is Approved for At-Home Use

FluMist is now authorized for at-home use, providing a needle-free flu vaccination option that increases accessibility.
The approval introduces a new alternative to traditional flu shots, particularly for children and those afraid of needles.
morepublic-health
#neuralink

Elon Musk's Neuralink brain chip receives FDA's 'breakthrough device' status - and could help blind people see again

Neuralink's Blindsight implant has been approved to assist blind patients, even those blind from birth, in regaining their sight.

Another patient will get Neuralink's brain implant

Neuralink approved for second brain implant procedure for patients with ALS, spinal cord injuries or quadriplegia.

Neuralink gets FDA approval for second brain implant patient: WSJ

The Neuralink brain implant company has gained FDA approval for human trials, with potential to restore autonomy to quadriplegic individuals.

FDA approves Neuralink's brain chip for second patient

Neuralink received FDA approval for second patient after resolving brain chip issues.

Tesla Optimus Gets a Handy Upgrade

Tesla's humanoid robot Optimus demonstrated upgraded hands with 22 degrees of freedom, coinciding with Neuralink's FDA approval for a new trial.

Elon Musk's Neuralink brain chip receives FDA's 'breakthrough device' status - and could help blind people see again

Neuralink's Blindsight implant has been approved to assist blind patients, even those blind from birth, in regaining their sight.

Another patient will get Neuralink's brain implant

Neuralink approved for second brain implant procedure for patients with ALS, spinal cord injuries or quadriplegia.

Neuralink gets FDA approval for second brain implant patient: WSJ

The Neuralink brain implant company has gained FDA approval for human trials, with potential to restore autonomy to quadriplegic individuals.

FDA approves Neuralink's brain chip for second patient

Neuralink received FDA approval for second patient after resolving brain chip issues.

Tesla Optimus Gets a Handy Upgrade

Tesla's humanoid robot Optimus demonstrated upgraded hands with 22 degrees of freedom, coinciding with Neuralink's FDA approval for a new trial.
moreneuralink

Calming Tremors

The GyroGlove is a groundbreaking device for stabilizing hands affected by essential tremors, significantly improving users' quality of life.
#apple

AirPods Pro 2 just became the best value hearing aids on the market

Apple's AirPods Pro 2 will feature a new FDA-authorized Hearing Aid mode, making them one of the most affordable options on the market.

Watch: FDA approval sets the stage for Apple's AirPod hearing aids

Apple's iOS 18 will allow AirPods to function as hearing aids for those with mild to moderate hearing loss, pending FDA approval.

Hands-On with the First FDA-Approved OTC Hearing Aid Software Device: Apple's AirPods Pro 2 Transform Accessibility - Yanko Design

Apple's Hearing Aid Feature for AirPods Pro 2 provides accessible and customizable hearing support without the need for professional fitting.

The Cutting-Edge Hearing Aids That You May Already Own

Apple's AirPods Pro 2 will soon function as inexpensive hearing aids due to new FDA-approved software features.

The Morning After: The AirPods Pro's new hearing aid features are a big deal

Apple introduced FDA-approved hearing aid features in AirPods Pro, integrating health technology with consumer devices via software updates.

FDA OKs Apple's AirPods Pro 2 as hearing aids

Apple's AirPods can now be marketed as affordable over-the-counter hearing aids following FDA approval, challenging the high-cost traditional hearing aid market.

AirPods Pro 2 just became the best value hearing aids on the market

Apple's AirPods Pro 2 will feature a new FDA-authorized Hearing Aid mode, making them one of the most affordable options on the market.

Watch: FDA approval sets the stage for Apple's AirPod hearing aids

Apple's iOS 18 will allow AirPods to function as hearing aids for those with mild to moderate hearing loss, pending FDA approval.

Hands-On with the First FDA-Approved OTC Hearing Aid Software Device: Apple's AirPods Pro 2 Transform Accessibility - Yanko Design

Apple's Hearing Aid Feature for AirPods Pro 2 provides accessible and customizable hearing support without the need for professional fitting.

The Cutting-Edge Hearing Aids That You May Already Own

Apple's AirPods Pro 2 will soon function as inexpensive hearing aids due to new FDA-approved software features.

The Morning After: The AirPods Pro's new hearing aid features are a big deal

Apple introduced FDA-approved hearing aid features in AirPods Pro, integrating health technology with consumer devices via software updates.

FDA OKs Apple's AirPods Pro 2 as hearing aids

Apple's AirPods can now be marketed as affordable over-the-counter hearing aids following FDA approval, challenging the high-cost traditional hearing aid market.
moreapple
#schizophrenia

A new kind of drug for schizophrenia promises fewer side effects

The FDA has approved Cobenfy, a new schizophrenia drug promising fewer side effects than existing medications.

For the first time in decades, we have a new kind of schizophrenia drug

Cobenfy is a groundbreaking drug that targets muscarinic receptors, potentially offering a new treatment avenue for schizophrenia sufferers.

FDA Approves the First New Schizophrenia Drug in Decades

Cobenfy is the first new schizophrenia treatment approved in 30 years, targeting the cholinergic system instead of dopamine.

F.D.A. Approves the First New Schizophrenia Drug in Decades

Cobenfy is the first new antipsychotic in decades, aiming to treat schizophrenia without severe side effects like weight gain.

A new kind of drug for schizophrenia promises fewer side effects

The FDA has approved Cobenfy, a new schizophrenia drug promising fewer side effects than existing medications.

For the first time in decades, we have a new kind of schizophrenia drug

Cobenfy is a groundbreaking drug that targets muscarinic receptors, potentially offering a new treatment avenue for schizophrenia sufferers.

FDA Approves the First New Schizophrenia Drug in Decades

Cobenfy is the first new schizophrenia treatment approved in 30 years, targeting the cholinergic system instead of dopamine.

F.D.A. Approves the First New Schizophrenia Drug in Decades

Cobenfy is the first new antipsychotic in decades, aiming to treat schizophrenia without severe side effects like weight gain.
moreschizophrenia
#medtech

Lapsi is rebooting the stethoscope as a health tracking data platform | TechCrunch

Lapsi Health's FDA-approved digital stethoscope represents progress in consumerization within the medtech industry.

Cambridge-based CMR Surgical secures FDA approval for revolutionary portable surgical robot

CMR Surgical has received FDA approval for its Versius Surgical System, enhancing access to robotic-assisted surgeries in the US market.

Lapsi is rebooting the stethoscope as a health tracking data platform | TechCrunch

Lapsi Health's FDA-approved digital stethoscope represents progress in consumerization within the medtech industry.

Cambridge-based CMR Surgical secures FDA approval for revolutionary portable surgical robot

CMR Surgical has received FDA approval for its Versius Surgical System, enhancing access to robotic-assisted surgeries in the US market.
moremedtech
#health-technology

FDA approves Apple Watch sleep apnea detection tool

Apple Watch now detects sleep apnea risk, promoting proactive health monitoring.

Apple Watch gets FDA approval for new sleep apnea detection

Apple's sleep apnea detection feature on WatchOS 11 has FDA approval for safety and effectiveness.

Apple's AirPods Are Becoming Actual Hearing Aids

The FDA has approved Apple AirPods as hearing aids for individuals with mild to moderate hearing impairment.

Apple Watch sleep apnea detection gets FDA approval | TechCrunch

Apple Watch Series 9, Series 10, and Watch Ultra 2 receive FDA approval for sleep apnea detection ahead of their release, boosting health monitoring capabilities.

DeepWell DTx receives FDA clearance for its therapeutic video game developer tools | TechCrunch

DeepWell's FDA-approved games provide an innovative tool to help treat stress, marking a shift towards digital therapies in mental health.

FDA approves Apple Watch sleep apnea detection tool

Apple Watch now detects sleep apnea risk, promoting proactive health monitoring.

Apple Watch gets FDA approval for new sleep apnea detection

Apple's sleep apnea detection feature on WatchOS 11 has FDA approval for safety and effectiveness.

Apple's AirPods Are Becoming Actual Hearing Aids

The FDA has approved Apple AirPods as hearing aids for individuals with mild to moderate hearing impairment.

Apple Watch sleep apnea detection gets FDA approval | TechCrunch

Apple Watch Series 9, Series 10, and Watch Ultra 2 receive FDA approval for sleep apnea detection ahead of their release, boosting health monitoring capabilities.

DeepWell DTx receives FDA clearance for its therapeutic video game developer tools | TechCrunch

DeepWell's FDA-approved games provide an innovative tool to help treat stress, marking a shift towards digital therapies in mental health.
morehealth-technology

You can get an at-home flu 'shot' starting next year

FluMist nasal spray vaccine approved for home use, offering convenience and accessibility to flu immunization.
#gene-therapy

Sickle cell gene therapies roll out slowly

FDA has approved the first genetic treatments for sickle cell disease, offering new hope to patients like Olaide Adekanbi.

Lifesaving gene therapy for kids is world's priciest drug at $4.25M

Gene therapy approved for rare disease dramatically improves quality of life for children.
High price of the therapy raises concerns about affordability and access.

Sickle cell gene therapies roll out slowly

FDA has approved the first genetic treatments for sickle cell disease, offering new hope to patients like Olaide Adekanbi.

Lifesaving gene therapy for kids is world's priciest drug at $4.25M

Gene therapy approved for rare disease dramatically improves quality of life for children.
High price of the therapy raises concerns about affordability and access.
moregene-therapy

Luminate's hair-saving chemo helmet nears release, as new funding goes toward home cancer care | TechCrunch

Luminate's wearable device effectively prevents hair loss during chemotherapy and is poised for a U.S. trial toward FDA clearance.
#airpods-pro-2

Apple AirPods Pro granted FDA approval to serve as hearing aids | TechCrunch

The AirPods Pro 2 can now function as an over-the-counter hearing aid with a software update, enhancing accessibility for hearing support.

AirPods Pro 2 can now function as Hearing Aids after FDA grands Apple approval - Yanko Design

Apple's AirPods Pro 2 redefine personal tech by gaining FDA approval as hearing aids, emphasizing health monitoring and affordability.

Apple AirPods Pro granted FDA approval to serve as hearing aids | TechCrunch

The AirPods Pro 2 can now function as an over-the-counter hearing aid with a software update, enhancing accessibility for hearing support.

AirPods Pro 2 can now function as Hearing Aids after FDA grands Apple approval - Yanko Design

Apple's AirPods Pro 2 redefine personal tech by gaining FDA approval as hearing aids, emphasizing health monitoring and affordability.
moreairpods-pro-2

Apple Receives FDA Approval to Enable AirPods Pro 2 Hearing Aids Feature

AirPods Pro (2nd Generation) will serve as the first over-the-counter hearing aid in the US, approved by the FDA.
#weight-loss-medications

The next big market for weight-loss drugs: children

Novo Nordisk's Saxenda can significantly reduce children's BMI, showing potential for FDA approval in a market with currently no approved obesity medications for children.

Hims & Hers Health stock price nears record high on news that it will offer GLP-1 weight-loss drugs amid shortages

Hims & Hers Health announced the addition of GLP-1 injectable drugs to its offerings at significantly reduced prices, leading to a surge in stock prices.

The next big market for weight-loss drugs: children

Novo Nordisk's Saxenda can significantly reduce children's BMI, showing potential for FDA approval in a market with currently no approved obesity medications for children.

Hims & Hers Health stock price nears record high on news that it will offer GLP-1 weight-loss drugs amid shortages

Hims & Hers Health announced the addition of GLP-1 injectable drugs to its offerings at significantly reduced prices, leading to a surge in stock prices.
moreweight-loss-medications
#weight-loss

Scientists Confirmed An Important Connection Between Semaglutide and Mental Health

Semaglutide is safe for mental health in obese patients without prior disorders, showing no increase in depression or suicidal thoughts.

Bella Thorne Spoke Out About Ozempic As She Candidly Recalled Feeling Insecure In Her Body

Despite not being FDA-approved for weight loss, Ozempic is gaining popularity for this off-label use.

Is Wegovy Covered By Insurance? These Insurers Offer Coverage | Entrepreneur

Major health insurance companies in the U.S. are starting to cover Novo Nordisk's weight loss injection Wegovy.
The FDA approved Wegovy for heart health after a study showed it could reduce the risk of heart attack and stroke by 20%.

Scientists Confirmed An Important Connection Between Semaglutide and Mental Health

Semaglutide is safe for mental health in obese patients without prior disorders, showing no increase in depression or suicidal thoughts.

Bella Thorne Spoke Out About Ozempic As She Candidly Recalled Feeling Insecure In Her Body

Despite not being FDA-approved for weight loss, Ozempic is gaining popularity for this off-label use.

Is Wegovy Covered By Insurance? These Insurers Offer Coverage | Entrepreneur

Major health insurance companies in the U.S. are starting to cover Novo Nordisk's weight loss injection Wegovy.
The FDA approved Wegovy for heart health after a study showed it could reduce the risk of heart attack and stroke by 20%.
moreweight-loss
#nasal-spray

EpiPen gets a new competitor: FDA approves anaphylaxis nasal spray

Nasal spray with epinephrine approved by FDA for severe allergic reactions

A needle-less alternative to EpiPen has FDA approval. Will doctors prescribe it?

The newly approved nasal spray Neffy offers a potential alternative to EpiPens, but concerns remain regarding its efficacy in treating life-threatening allergic reactions.

EpiPen gets a new competitor: FDA approves anaphylaxis nasal spray

Nasal spray with epinephrine approved by FDA for severe allergic reactions

A needle-less alternative to EpiPen has FDA approval. Will doctors prescribe it?

The newly approved nasal spray Neffy offers a potential alternative to EpiPens, but concerns remain regarding its efficacy in treating life-threatening allergic reactions.
morenasal-spray

The New COVID-19 Vaccine You Should Get This Fall

Updated COVID-19 vaccines for 2024-2025 will target the KP.2 variant to combat rising infections amid ongoing virus mutations.
#clinical-trials

An exciting time:' Breakthroughs coming to treat and prevent hair loss

Young people experience early hair loss due to anxiety and poor diet. FDA-approved treatments are limited, but new medications and therapies are in clinical trials.

As the FDA evaluates ecstasy treatment for PTSD, questions mount about the evidence

MDMA's potential for PTSD treatment faces uncertainty in FDA approval.

3 Trending Biotech Penny Stocks

Biotech stocks can yield high returns while benefiting patients; they're influenced by clinical trials and regulatory decisions.

An exciting time:' Breakthroughs coming to treat and prevent hair loss

Young people experience early hair loss due to anxiety and poor diet. FDA-approved treatments are limited, but new medications and therapies are in clinical trials.

As the FDA evaluates ecstasy treatment for PTSD, questions mount about the evidence

MDMA's potential for PTSD treatment faces uncertainty in FDA approval.

3 Trending Biotech Penny Stocks

Biotech stocks can yield high returns while benefiting patients; they're influenced by clinical trials and regulatory decisions.
moreclinical-trials
#medical-innovation

The FDA just cleared a new device that stops bleeding from gunshot wounds in seconds

Traumagel is a new hemostatic gel that can quickly stop severe bleeding, promising to revolutionize how emergencies are treated.

FDA Approves Futuristic Gel That Can Stop Life-Threatening Bleeding in Seconds

The FDA has approved Traumagel, a gel that can quickly stop severe bleeding from life-threatening injuries, revolutionizing emergency medical response.

The FDA just cleared a new device that stops bleeding from gunshot wounds in seconds

Traumagel is a new hemostatic gel that can quickly stop severe bleeding, promising to revolutionize how emergencies are treated.

FDA Approves Futuristic Gel That Can Stop Life-Threatening Bleeding in Seconds

The FDA has approved Traumagel, a gel that can quickly stop severe bleeding from life-threatening injuries, revolutionizing emergency medical response.
moremedical-innovation
#psychedelics

Can psychedelics treat depression? Maybe, and you might not even have to take a trip

Dextromethorphan, a common ingredient in cough medications known for recreational use, is being repurposed as part of a legally approved antidepressant treatment by Axsome Therapeutics.

The FDA Didn't Approve MDMA. Is the Medical System Ready for Any Psychedelic?

FDA rejected MDMA for PTSD therapy due to insufficient data, raising doubts about psychedelics' future in U.S. medical system.

Can psychedelics treat depression? Maybe, and you might not even have to take a trip

Dextromethorphan, a common ingredient in cough medications known for recreational use, is being repurposed as part of a legally approved antidepressant treatment by Axsome Therapeutics.

The FDA Didn't Approve MDMA. Is the Medical System Ready for Any Psychedelic?

FDA rejected MDMA for PTSD therapy due to insufficient data, raising doubts about psychedelics' future in U.S. medical system.
morepsychedelics

Lawmakers push for more consideration into MDMA-assisted therapy for veterans

Veterans are advocating for FDA approval of MDMA-assisted therapy to help with PTSD.
#blood-test

A new blood test can spot signs of colon cancer in your annual blood draw

The FDA has approved a blood test for colon cancer screening, making it more accessible and potentially saving lives.

There's Now an FDA-Approved Blood Test for Colon Cancer

The FDA approved a new blood test for colon cancer screening in average-risk adults. This noninvasive test may improve screening rates and supplement colonoscopy screenings.

Everything you need to know about the new colon cancer blood test

The FDA approved a new blood test, Shield, by Guardant Health, to screen for colon cancer, enhancing early detection and affordability.

FDA approves blood test to detect early signs of colorectal cancer - Queerty

The FDA approved a new blood test called 'Shield' by Guardant Health for early detection of colorectal cancer in at-risk individuals over 45, increasing chances of survival.

A simple blood test can detect colorectal cancer early, study finds

Blood test can detect 83% of colorectal cancer cases
FDA approval could offer a less invasive screening option

A Blood Test for Colon Cancer Shows Promise

Blood test for colon cancer showed 83% accuracy in detecting cancers.
Colonoscopies remain the gold standard for colon cancer screening, detecting both tumors and precancerous growths.

A new blood test can spot signs of colon cancer in your annual blood draw

The FDA has approved a blood test for colon cancer screening, making it more accessible and potentially saving lives.

There's Now an FDA-Approved Blood Test for Colon Cancer

The FDA approved a new blood test for colon cancer screening in average-risk adults. This noninvasive test may improve screening rates and supplement colonoscopy screenings.

Everything you need to know about the new colon cancer blood test

The FDA approved a new blood test, Shield, by Guardant Health, to screen for colon cancer, enhancing early detection and affordability.

FDA approves blood test to detect early signs of colorectal cancer - Queerty

The FDA approved a new blood test called 'Shield' by Guardant Health for early detection of colorectal cancer in at-risk individuals over 45, increasing chances of survival.

A simple blood test can detect colorectal cancer early, study finds

Blood test can detect 83% of colorectal cancer cases
FDA approval could offer a less invasive screening option

A Blood Test for Colon Cancer Shows Promise

Blood test for colon cancer showed 83% accuracy in detecting cancers.
Colonoscopies remain the gold standard for colon cancer screening, detecting both tumors and precancerous growths.
moreblood-test
from www.npr.org
4 months ago

Can a lobbying push led by veterans help MDMA get approved for PTSD treatment?

MDMA-assisted therapy for PTSD is under FDA review, with veterans and various advocates pushing for its approval against initial skepticism and setbacks.
#guardant-health

FDA approves Silicon Valley company's blood test for colorectal cancer screening among average-risk adults in the US

A blood test by Guardant Health received FDA approval for colorectal cancer screening, marking the first blood test approved as a primary screening option, promising convenience and early detection potential.

F.D.A. Approves Blood Test for Colon Cancer Detection

The FDA approved a new blood test for colorectal cancer, simpler than other screening methods, aiming to increase early-stage cancer detection and reduce cancer-related deaths.

FDA approves Silicon Valley company's blood test for colorectal cancer screening among average-risk adults in the US

A blood test by Guardant Health received FDA approval for colorectal cancer screening, marking the first blood test approved as a primary screening option, promising convenience and early detection potential.

F.D.A. Approves Blood Test for Colon Cancer Detection

The FDA approved a new blood test for colorectal cancer, simpler than other screening methods, aiming to increase early-stage cancer detection and reduce cancer-related deaths.
moreguardant-health

FDA approves blood test for colorectal cancer

Blood test approved by FDA for colorectal cancer detection in individuals aged 45 and older, offering an additional screening option.
Detection limitations: The Shield test may not detect early-stage colorectal cancer and misses 87% of precancerous growths, not replacing a colonoscopy.
State of play: Shield test by Guardant to launch soon with FDA approval, becoming the first blood test for colorectal cancer for average-risk individuals eligible for Medicare coverage.
#alzheimers-disease

Luke O'Neill: Are we seeing the beginning of the end for the devastating disease that is Alzheimer's?

A new drug called Kisunla has been approved by the FDA to treat early symptoms of Alzheimer's disease.

Blood Tests for Alzheimer's May Be Coming to Your Doctor's Office

New blood tests for Alzheimer's are promising but need more evidence for widespread adoption.

Luke O'Neill: Are we seeing the beginning of the end for the devastating disease that is Alzheimer's?

A new drug called Kisunla has been approved by the FDA to treat early symptoms of Alzheimer's disease.

Blood Tests for Alzheimer's May Be Coming to Your Doctor's Office

New blood tests for Alzheimer's are promising but need more evidence for widespread adoption.
morealzheimers-disease

Moderna secures a second FDA vaccine approval as Spikevax sales plummet

Moderna's mRESVIA vaccine approved by FDA for adults 60 and older, showing high efficacy against RSV.
#bladder-cancer

New Biomarker May Predict Treatment Response in Bladder Cancer - News Center

Patients with metastatic urothelial cancer and high NECTIN4 gene expression respond significantly better to enfortumab vedotin treatment.

FDA approves bladder cancer treatment by Culver City company

FDA approved new bladder cancer treatment Anktiva by ImmunityBio, activating immune response in patients who didn't respond to prior therapies.

New Biomarker May Predict Treatment Response in Bladder Cancer - News Center

Patients with metastatic urothelial cancer and high NECTIN4 gene expression respond significantly better to enfortumab vedotin treatment.

FDA approves bladder cancer treatment by Culver City company

FDA approved new bladder cancer treatment Anktiva by ImmunityBio, activating immune response in patients who didn't respond to prior therapies.
morebladder-cancer

Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval - MedCity News

FDA approved a new Amgen drug, Imdelltra, for second-line treatment of small cell lung cancer, offering patients another option.

F.D.A. Approves Drug for Persistently Deadly Form of Lung Cancer

The FDA approved a new treatment, tarlatamab, for small cell lung cancer patients with limited life expectancy, showing potential with tripled life expectancy and practice-changing impact.

Apple Watch AFib feature receives new FDA approval - can now be used in clinical studies - Wareable

The Apple Watch's AFib feature is the first 'digital health technology' to receive MMDT approval from the FDA, allowing its use in clinical studies.
#clinical-trial

Skin Patch Improves Treatment for Pediatric Milk Allergies - News Center

Daily immunotherapy via dermal patch reduced risks in children with cow's milk allergy.

$158,000 ALS drug pulled from market after failing in large clinical trial

The drug Relyvrio, approved for ALS treatment, did not show benefits in a clinical trial and is being pulled from the market.
The FDA approved Relyvrio despite shaky data, and the drug's failure highlights the need for more effective ALS treatments.

Skin Patch Improves Treatment for Pediatric Milk Allergies - News Center

Daily immunotherapy via dermal patch reduced risks in children with cow's milk allergy.

$158,000 ALS drug pulled from market after failing in large clinical trial

The drug Relyvrio, approved for ALS treatment, did not show benefits in a clinical trial and is being pulled from the market.
The FDA approved Relyvrio despite shaky data, and the drug's failure highlights the need for more effective ALS treatments.
moreclinical-trial

DEA to reclassify marijuana as a lower-risk drug, reports say

The US Drug Enforcement Administration is poised to reclassify marijuana to a lower-risk drug category, aligning with health department recommendations and acknowledging potential medical benefits.

F.D.A. Approves Antibiotic for Increasingly Hard-to-Treat Urinary Tract Infections

Pivmecillinam, a new antibiotic approved by the FDA for UTIs, offers a crucial solution for the increasing resistance to existing antimicrobial drugs.

What's News, Breaking: Wednesday, April 3, 2024

New drug Zevtera approved by FDA to treat certain staph infections.
Elected officials aim to address the issue of squatters invading and vandalizing buildings.

Merck Drug for Heart and Lung Disorder Wins a First-in-Class FDA Approval

Pulmonary arterial hypertension (PAH) is a rare form of hypertension affecting lung arteries, leading to heart problems.
FDA approved a new Merck drug, Winrevair (sotatercept), which targets an underlying cause of PAH and helps alleviate symptoms.

The Real Reason Why Some Abortion Pill Patients Go to the ER

The safety of mifepristone is a central issue in the case challenging FDA approval.
Emergency room visits following medication abortion are not necessarily indicative of safety concerns.
#medicare-coverage

Medicare plans can now cover Wegovy for patients at risk of heart disease

Medicare to cover the obesity drug Wegovy for preventing heart attacks and strokes
Medicare guidance allows coverage for FDA-approved anti-obesity medications with additional benefits

How Medicare can start covering a popular weight-loss drug for more people

Medicare may cover anti-obesity drug Wegovy for cardiovascular risks
Drug companies seek FDA approval for weight-loss drugs for various other conditions

Does Medicare cover Wegovy? Insurance provider could start covering certain weight loss drugs

Medicare may cover Wegovy for certain beneficiaries with heart disease.
CMS guidance allows using FDA-approved medications for specific uses under Part D plans.

Medicare plans can now cover Wegovy for patients at risk of heart disease

Medicare to cover the obesity drug Wegovy for preventing heart attacks and strokes
Medicare guidance allows coverage for FDA-approved anti-obesity medications with additional benefits

How Medicare can start covering a popular weight-loss drug for more people

Medicare may cover anti-obesity drug Wegovy for cardiovascular risks
Drug companies seek FDA approval for weight-loss drugs for various other conditions

Does Medicare cover Wegovy? Insurance provider could start covering certain weight loss drugs

Medicare may cover Wegovy for certain beneficiaries with heart disease.
CMS guidance allows using FDA-approved medications for specific uses under Part D plans.
moremedicare-coverage
#wegovy

Wegovy Moves Beyond Weight Loss

Wegovy now approved for reducing cardiovascular risks in adults with heart disease and obesity
F.D.A. approval based on study showing Wegovy reduced heart attacks and strokes

The FDA recently approved semaglutide (Wegovy) for preventing serious heart conditions in some people, but questions remain about how it works

Semaglutide (Wegovy) approved by FDA to prevent serious cardiovascular conditions for high-risk individuals
The approval expands the use of semaglutide to overweight or obese individuals with a history of cardiac events

Wegovy is no longer just a weight-loss drug

Wegovy was approved by the FDA to reduce the risk of major cardiovascular events in obese or overweight adults with established cardiovascular disease.
Wegovy has been shown to reduce the risk of major adverse cardiac events by 20%, cardiovascular death by 15%, and death from any cause by 19%.

Wegovy Moves Beyond Weight Loss

Wegovy now approved for reducing cardiovascular risks in adults with heart disease and obesity
F.D.A. approval based on study showing Wegovy reduced heart attacks and strokes

The FDA recently approved semaglutide (Wegovy) for preventing serious heart conditions in some people, but questions remain about how it works

Semaglutide (Wegovy) approved by FDA to prevent serious cardiovascular conditions for high-risk individuals
The approval expands the use of semaglutide to overweight or obese individuals with a history of cardiac events

Wegovy is no longer just a weight-loss drug

Wegovy was approved by the FDA to reduce the risk of major cardiovascular events in obese or overweight adults with established cardiovascular disease.
Wegovy has been shown to reduce the risk of major adverse cardiac events by 20%, cardiovascular death by 15%, and death from any cause by 19%.
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First US drug approved for a liver disease surging around the world

First FDA-approved drug for a liver disease linked to obesity
Resmetirom approved to treat metabolic dysfunction-associated steatohepatitis (MASH)

Researchers call for a major rethink of how Alzheimer's treatments are evaluated

Lecanemab approved by FDA for Alzheimer's treatment
Disease-modifying drugs target root cause and offer cumulative benefits

The Ozempic Revolution Is Stuck

Obesity drugs like Wegovy were originally created for different purposes, now being repurposed for heart health.
FDA approval of Wegovy for heart health could open access to more Americans, but drug shortages remain a significant barrier.
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