#fda-approval
#fda-approval

3 weeks ago

New Jersey teen pain-free thanks to new sickle cell disease treatment

A groundbreaking gene therapy offers a potential cure for sickle cell disease, marking a significant advancement in treatment.

Parenting

fromArs Technica

The remarkable timeline of a custom gene-editing therapy to save a newborn

KJ received groundbreaking gene-editing therapy at just six months old, showcasing rapid advancements in clinical trial processes.

Venture

fromMedCity News

Cash-Strapped Gene Therapy Firm Bluebird Bio Agrees to Acquisition by Private Equity - MedCity News

Bluebird Bio has agreed to sell itself to private equity firms Carlyle and SK Capital for $29 million to stabilize its gene therapy commercialization efforts.

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.

SF parents

3 weeks ago

New Jersey teen pain-free thanks to new sickle cell disease treatment

A groundbreaking gene therapy offers a potential cure for sickle cell disease, marking a significant advancement in treatment.

Parenting

fromArs Technica

The remarkable timeline of a custom gene-editing therapy to save a newborn

KJ received groundbreaking gene-editing therapy at just six months old, showcasing rapid advancements in clinical trial processes.

Venture

fromMedCity News

Cash-Strapped Gene Therapy Firm Bluebird Bio Agrees to Acquisition by Private Equity - MedCity News

Bluebird Bio has agreed to sell itself to private equity firms Carlyle and SK Capital for $29 million to stabilize its gene therapy commercialization efforts.

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.

First FDA-cleared Alzheimer's blood test could make diagnoses faster, more accurate

A new FDA-cleared blood test for Alzheimer's can significantly improve diagnosis and treatment for patients.

Medicine

FDA approves blood test that can help diagnose Alzheimer's disease

Wearables

The FDA Just Approved an Alzheimer's Disease Blood Test

fromwww.npr.org

4 weeks ago

First FDA-cleared Alzheimer's blood test could make diagnoses faster, more accurate

A new FDA-cleared blood test for Alzheimer's can significantly improve diagnosis and treatment for patients.

FDA approves blood test that can help diagnose Alzheimer's disease

FDA endorses first blood test for diagnosing Alzheimer's disease, enhancing accessibility and accuracy for patients.

The FDA Just Approved an Alzheimer's Disease Blood Test

The FDA approved a blood test for Alzheimer's disease, enhancing early detection and accessibility.

more#alzheimers-disease

#healthcare

fromFast Company

Medicine

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

fromAbove the Law

Intellectual property law

Into The Sun: Federal Circuit Provides Clarity On The Role Of Injunctions In Pharma Cases - Above the Law

fromThe Nation

NYC politics

Inside the Bloodbath at the NIH

fromFast Company

Medicine

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

fromAbove the Law

Intellectual property law

Into The Sun: Federal Circuit Provides Clarity On The Role Of Injunctions In Pharma Cases - Above the Law

fromThe Nation

NYC politics

Inside the Bloodbath at the NIH

Study Shows Ubrogepant Can Address Non-Headache Symptoms

Ubrogepant shows potential to treat migraine-related symptoms beyond headaches, including photophobia and cognitive dysfunction.

#cervical-cancer

Cancer

First at-home test kit for cervical cancer approved by the FDA, company says

FDA approves the first at-home cervical cancer testing kit, enhancing access to HPV screening for women.

fromThe Washington Post

What to know about the first at-home Pap smear approved by the FDA

The FDA approved a new at-home cervical cancer screening tool, improving access for women to detect cervical cancer.

Cancer

First at-home test kit for cervical cancer approved by the FDA, company says

FDA approves the first at-home cervical cancer testing kit, enhancing access to HPV screening for women.

fromThe Washington Post

What to know about the first at-home Pap smear approved by the FDA

The FDA approved a new at-home cervical cancer screening tool, improving access for women to detect cervical cancer.

FDA Approves Gene-Hacked CRISPR Pigs for Human Consumption

The FDA has approved a CRISPR gene-edited pig for human consumption, targeting a major viral disease affecting the pork industry.

We're Getting Closer to Edible GLP-1 Drugs Being Available

The rise of oral GLP-1 medications could revolutionize diabetes and weight loss treatments, with several companies currently in clinical trials.

#public-health

Coronavirus

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

8 months ago

Health

An FDA Ruling Could Make Nasal Vaccines Much More Widespread

Coronavirus

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

8 months ago

Health

An FDA Ruling Could Make Nasal Vaccines Much More Widespread

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.

Everything to know about the new weight loss pill that works as well as Ozempic - and when you can get it

Eli Lilly's orforglipron offers a stab-free treatment for diabetes and obesity, with potential FDA approval enhancing its market presence.

fromwww.nytimes.com

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.

Everything to know about the new weight loss pill that works as well as Ozempic - and when you can get it

Eli Lilly's orforglipron offers a stab-free treatment for diabetes and obesity, with potential FDA approval enhancing its market presence.

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.

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.

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.

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.

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.

FDA approves siRNA drug for haemophilia prophylaxis

Fitusiran has received FDA approval for hemophilia prophylaxis, with a dosing schedule that enhances convenience for patients.

fromwww.mercurynews.com

SF food

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

FDA approves siRNA drug for haemophilia prophylaxis

Fitusiran has received FDA approval for hemophilia prophylaxis, with a dosing schedule that enhances convenience for patients.

fromwww.mercurynews.com

fromIPWatchdog.com | Patents & Intellectual Property Law

SF food

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

more#biotechnology

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

The common law experimental use exemption particularly narrows patent infringement protections, applying only to non-commercial, purely experimental uses, posing significant risks for researchers.

Intellectual property law

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.

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.

Pixel Watch 3 gets FDA approval to alert you if you're dying

The Pixel Watch 3 now includes FDA-approved Loss of Pulse Detection, enhancing health monitoring capabilities.

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.

fromArs Technica

Pixel Watch 3 gets FDA approval to alert you if you're dying

The Pixel Watch 3 now includes FDA-approved Loss of Pulse Detection, enhancing health monitoring capabilities.

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.

fromtime.com

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.

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

Medicine

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

fromwww.nytimes.com

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

Medicine

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

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

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

Medicine

US drug agency approves potent painkiller - the first non-opioid in decades

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

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

Medicine

US drug agency approves potent painkiller - the first non-opioid in decades

more#pain-management

fromAdweek

R/GA Wins Eli Lilly Social Business

Eli Lilly has appointed R/GA as its social agency of record to manage social media for its GLP-1 drug, Zepbound, and other brands.

Medicine

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.

fromtime.com

5 months ago

Medicine

The First Sleep Apnea Drug Is Here