#fda-approval
#fda-approval

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.

Coronavirus

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.

fromThe New Yorker

5 months ago

Left-wing politics

Is Contraception Under Attack?

The birth-control pill can now be purchased over the counter in the U.S. for the first time, significantly improving access.

fromwww.bostonherald.com

1 week ago

Coronavirus

Novavax says its COVID-19 shot is on track for full FDA approval after delay

Novavax's COVID-19 vaccine is progressing towards full FDA approval, which would secure its market presence indefinitely.

Health

An FDA Ruling Could Make Nasal Vaccines Much More Widespread

The FDA has approved the FluMist nasal vaccine for home use, enhancing convenience and accessibility for flu vaccinations.

US news

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.

Coronavirus

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.

fromThe New Yorker

5 months ago

Left-wing politics

Is Contraception Under Attack?

The birth-control pill can now be purchased over the counter in the U.S. for the first time, significantly improving access.

fromwww.bostonherald.com

1 week ago

Coronavirus

Novavax says its COVID-19 shot is on track for full FDA approval after delay

Novavax's COVID-19 vaccine is progressing towards full FDA approval, which would secure its market presence indefinitely.

Health

An FDA Ruling Could Make Nasal Vaccines Much More Widespread

The FDA has approved the FluMist nasal vaccine for home use, enhancing convenience and accessibility for flu vaccinations.

Pig livers for people: US regulator greenlights first safety trial

FDA approved trial for genetically modified pig livers to treat organ failure is a significant step in xenotransplantation.

fromNature

The science behind the first pig-organ transplant trial in humans

The FDA has approved a trial for pig kidney transplantation in humans, marking a significant step towards alleviating organ donor shortages.

fromWashington Post

Medicine

FDA approves pig organ transplant trials for patients with kidney failure

The FDA has approved clinical trials for organ transplants using genetically modified pigs, a potential solution for the kidney transplant shortage.

fromNature

3 weeks ago

Pig livers for people: US regulator greenlights first safety trial

FDA approved trial for genetically modified pig livers to treat organ failure is a significant step in xenotransplantation.

fromNature

The science behind the first pig-organ transplant trial in humans

The FDA has approved a trial for pig kidney transplantation in humans, marking a significant step towards alleviating organ donor shortages.

fromWashington Post

Medicine

FDA approves pig organ transplant trials for patients with kidney failure

The FDA has approved clinical trials for organ transplants using genetically modified pigs, a potential solution for the kidney transplant shortage.

more#xenotransplantation

#healthcare-innovation

US health agency approves brand-new painkiller DW 01/31/2025

The FDA approved suzetrigine, a non-opioid painkiller, providing effective relief for moderate to severe pain without addiction risks.

New Form of Parkinson's Treatment Uses Real-Time Deep-Brain Stimulation

Deep-brain stimulation technology has dramatically improved symptoms for Parkinson's patients, reducing medication and enhancing quality of life.

Mental health

fromwww.theguardian.com

Painkillers without the addiction? The new wave of non-opioid pain relief

FDA approves non-opioid painkiller suzetrigine, marking a significant advancement in pain management amid the opioid crisis.

US health agency approves brand-new painkiller DW 01/31/2025

The FDA approved suzetrigine, a non-opioid painkiller, providing effective relief for moderate to severe pain without addiction risks.

New Form of Parkinson's Treatment Uses Real-Time Deep-Brain Stimulation

Deep-brain stimulation technology has dramatically improved symptoms for Parkinson's patients, reducing medication and enhancing quality of life.

Mental health

fromwww.theguardian.com

more#healthcare-innovation

Painkillers without the addiction? The new wave of non-opioid pain relief

FDA approves non-opioid painkiller suzetrigine, marking a significant advancement in pain management amid the opioid crisis.

SF food

fromwww.mercurynews.com

Tiny Silicon Valley drugmaker soars on FDA win to treat never-ending hunger

Soleno Therapeutics' Vykat XR receives FDA approval for treating insatiable hunger linked to Prader-Willi syndrome, boosting stock significantly.

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.

EU data protection

fromwww.mcall.com

Patient dies following muscular dystrophy gene therapy, Sarepta reports

A patient died from acute liver injury while using Sarepta's Elevidys gene therapy for muscular dystrophy, causing a major stock market reaction.

OMG science

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.

EU data protection

fromwww.mcall.com

fromIPWatchdog.com | Patents & Intellectual Property Law

Patient dies following muscular dystrophy gene therapy, Sarepta reports

A patient died from acute liver injury while using Sarepta's Elevidys gene therapy for muscular dystrophy, causing a major stock market reaction.

more#gene-therapy

Intellectual property law

Treading Carefully: How to Navigate the Common Law Research Exemption and the Hatch-Waxman Safe Harbor

The common law experimental use exemption offers narrow protections against patent infringement, which poses challenges for scientific research activities.

Courts are increasingly focused on the commercial implications of activities within the context of patent rights.

Privacy professionals

fromSlate Magazine

RFK Jr. Wants to Fast-Track Psychedelic Therapy. That's a Disaster in the Making.

The New York Times article inaccurately blames Psymposia for the failure of MDMA therapy approval, overshadowing the true complexities of the situation.

#epinephrine

SF parents

fromwww.mercurynews.com

California biotech company gets FDA approval for EpiPen alternative for kids

A new FDA-approved nasal spray offers a needle-free alternative to EpiPens for treating severe allergic reactions in children aged 4 and up.

Medicine

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.

SF parents

fromwww.mercurynews.com

California biotech company gets FDA approval for EpiPen alternative for kids

A new FDA-approved nasal spray offers a needle-free alternative to EpiPens for treating severe allergic reactions in children aged 4 and up.

Medicine

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.

Your Google Pixel Watch 3 is about to get a life-saving update - for free

The Pixel Watch 3's Loss of Pulse Detection feature provides life-saving capabilities by alerting emergency services in cases of cardiac arrest.

fromTheregister

FDA clears Google watch feature to call 911 if you flatline

The FDA has approved the Loss of Pulse Detection feature for the Pixel Watch 3, alerting users of imminent death.

fromZDNET

Your Google Pixel Watch 3 is about to get a life-saving update - for free

The Pixel Watch 3's Loss of Pulse Detection feature provides life-saving capabilities by alerting emergency services in cases of cardiac arrest.

fromTheregister

FDA clears Google watch feature to call 911 if you flatline

The FDA has approved the Loss of Pulse Detection feature for the Pixel Watch 3, alerting users of imminent death.

FDA Approves New Hormone-Free Copper IUD, Miudella

FDA approves Miudella, a new hormone-free copper IUD, the first in over 40 years.

Parkinson's Patients Have a New Way to Manage Their Symptoms

FDA approved a new adaptive deep brain stimulator for Parkinson's disease, offering personalized treatment that responds to abnormal brain signals.

#weight-loss

fromInverse

Medicine

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.

Health

Weight-Loss Drugs Like Ozempic Can Help Alcohol Addiction

Semaglutide, used for weight loss, may help reduce alcohol cravings and consumption in people with alcohol use disorder.

Medicine

The First Sleep Apnea Drug Is Here

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

fromInverse

Medicine

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.

Health

Weight-Loss Drugs Like Ozempic Can Help Alcohol Addiction

Semaglutide, used for weight loss, may help reduce alcohol cravings and consumption in people with alcohol use disorder.

Medicine

The First Sleep Apnea Drug Is Here

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

F.D.A. Approves Studies of Pig Organ Transplants for Kidney Patients

FDA approves clinical trials for organ transplants from genetically modified pigs, marking a significant advancement in cross-species transplantation.

Alternative medicine

Brand-new painkiller approved by US health agency DW 01/31/2025

Suzetrigine, a new painkiller, offers relief without the addictive potential of opioids, marking a significant advancement in pain management.

Medicine

What Is Journavx, the New Opioid-Free Painkiller from Vertex?

Suzetrigine is a groundbreaking painkiller approved by the FDA, providing an effective alternative to opioids without addiction risks.

F.D.A. Approves Studies of Pig Organ Transplants for Kidney Patients

FDA approves clinical trials for organ transplants from genetically modified pigs, marking a significant advancement in cross-species transplantation.

Alternative medicine

Brand-new painkiller approved by US health agency DW 01/31/2025

Suzetrigine, a new painkiller, offers relief without the addictive potential of opioids, marking a significant advancement in pain management.

Medicine

What Is Journavx, the New Opioid-Free Painkiller from Vertex?

Suzetrigine is a groundbreaking painkiller approved by the FDA, providing an effective alternative to opioids without addiction risks.

FDA Approves the First Non-Opioid Pain Drug in 20 Years

Suzetrigine offers a new non-addictive alternative for pain management, marking a significant advancement in pain relief treatments.

fromABC7 Los Angeles

FDA approves painkiller designed to eliminate the risk of addiction associated with opioids

A new pain pill, Journavx, offers an alternative to opioids without addiction risks, approved by the FDA for short-term pain relief.

Alternative medicine

New FDA Approval Could Transform Pain Management

Journavx has been approved by the FDA as a non-addictive painkiller for acute pain management.

Alternative medicine

FDA OK's painkiller designed to end opioids' addiction and overdose risk

Journavx offers a new pain management solution without the addiction risks of opioids.

fromBoston.com

Medicine

FDA approves drug from Boston-based company to treat pain without opioid effects

Suzetrigine, a non-addictive pain relief drug, is now approved by the FDA and promises a safer alternative to opioids.

fromFast Company

Medicine

FDA approves non-opioid painkiller designed to eliminate risk of addiction

Vertex has received FDA approval for Journavx, a pain medication designed to mitigate addiction and overdose risks typically associated with opioids.

FDA Approves the First Non-Opioid Pain Drug in 20 Years

Suzetrigine offers a new non-addictive alternative for pain management, marking a significant advancement in pain relief treatments.

fromABC7 Los Angeles

FDA approves painkiller designed to eliminate the risk of addiction associated with opioids

A new pain pill, Journavx, offers an alternative to opioids without addiction risks, approved by the FDA for short-term pain relief.

Alternative medicine

New FDA Approval Could Transform Pain Management

Journavx has been approved by the FDA as a non-addictive painkiller for acute pain management.

Alternative medicine

FDA OK's painkiller designed to end opioids' addiction and overdose risk

Journavx offers a new pain management solution without the addiction risks of opioids.

fromBoston.com

Medicine

FDA approves drug from Boston-based company to treat pain without opioid effects

Suzetrigine, a non-addictive pain relief drug, is now approved by the FDA and promises a safer alternative to opioids.

fromFast Company

Medicine

FDA approves non-opioid painkiller designed to eliminate risk of addiction

Vertex has received FDA approval for Journavx, a pain medication designed to mitigate addiction and overdose risks typically associated with opioids.

FDA approves Ozempic to reduce risks from chronic kidney disease in diabetes patients

Ozempic is FDA approved to reduce risks associated with chronic kidney disease in diabetes patients.

F.D.A. Approves Ozempic to Treat Kidney Disease

Ozempic has been approved to reduce complications for patients with type 2 diabetes and chronic kidney disease.

fromABC7 Los Angeles

FDA approves Ozempic to reduce risks from chronic kidney disease in diabetes patients

Ozempic is FDA approved to reduce risks associated with chronic kidney disease in diabetes patients.

F.D.A. Approves Ozempic to Treat Kidney Disease

Ozempic has been approved to reduce complications for patients with type 2 diabetes and chronic kidney disease.

Wellness

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.

fromAdweek

Medicine

R/GA Wins Eli Lilly Social Business

Eli Lilly has appointed R/GA to manage social media for its Zepbound weight-loss drug and other brands.

FDA approval of Zepbound opens a new market for Eli Lilly in sleep apnea treatment.

Wellness

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.

fromAdweek

Medicine

R/GA Wins Eli Lilly Social Business

Eli Lilly has appointed R/GA to manage social media for its Zepbound weight-loss drug and other brands.

FDA approval of Zepbound opens a new market for Eli Lilly in sleep apnea treatment.

Transcranial Magnetic Stimulation for Teenage Depression

FDA approval of TMS for adolescents 15+ responds to rising mental health challenges in teens.

Medicine

FDA allows standalone use of nasal spray antidepressant Spravato (esketamine)

The FDA has approved Spravato as a standalone treatment for depression, marking a significant shift in its usage guidelines.

fromPsychology Today

Transcranial Magnetic Stimulation for Teenage Depression

FDA approval of TMS for adolescents 15+ responds to rising mental health challenges in teens.

Medicine

FDA allows standalone use of nasal spray antidepressant Spravato (esketamine)

The FDA has approved Spravato as a standalone treatment for depression, marking a significant shift in its usage guidelines.

FDA approves weight loss drug Zepbound to treat obstructive sleep apnea

Zepbound is the first FDA-approved drug for treating sleep apnea linked to obesity.

The drug aids in weight loss, which alleviates sleep apnea symptoms effectively.

fromTESLARATI

5 months ago

Medicine

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.

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.

UX design

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.

Digital life

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.

Apple's AirPods Pro hearing health tools could normalize wearing earbuds everywhere

Apple's new hearing health features for AirPods Pro 2 could significantly enhance personal health management and accessibility for hearing-related issues.

fromThe Verge

Apple's AirPods Pro 2 could forever change how people access hearing aids

Apple aims to revolutionize hearing assistance with an accessible, clinical-grade hearing aid feature in AirPods Pro 2.

Mobile UX

fromGSMArena.com

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.

UX design

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.

Digital life

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.

Apple's AirPods Pro hearing health tools could normalize wearing earbuds everywhere

Apple's new hearing health features for AirPods Pro 2 could significantly enhance personal health management and accessibility for hearing-related issues.

fromThe Verge

Apple's AirPods Pro 2 could forever change how people access hearing aids

Apple aims to revolutionize hearing assistance with an accessible, clinical-grade hearing aid feature in AirPods Pro 2.

more#apple

fromBusiness Matters

Medicine

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.

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.

Miscellaneous

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.

fromTechCrunch

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.

fromZDNET

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.

Miscellaneous

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.

fromTechCrunch

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.

more#health-technology

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.

Apple

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.

Startup companies

fromTechCrunch

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.

Apple

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 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.

fromBusiness Insider

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.

Startup companies

fromFast Company

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.