New nasal spray to reverse fentanyl and other opioid overdoses gets FDA approval
WASHINGTON — U.S. health regulators on Monday approved a new, easy-to-use version of a medication…
Category: FDA
STAT+: FDA official offers insights into whether gene therapy makers could use common manufacturing process
WASHINGTON — A Food and Drug Administration official provided some insights this week into the…
FDA advisory panel backs Pfizer’s RSV vaccine, but expresses some safety concerns
A committee of vaccine experts voted to recommend the Food and Drug Administration approve Pfizer’s…
Federal judges question FDA authority in abortion pill hearing
A federal appeals court heard opening arguments Wednesday in a case that could determine the…
STAT+: Could an upcoming Supreme Court case make the FDA slower?
WASHINGTON — The Food and Drug Administration could take longer to write regulations and make…
STAT+: AI leaders issue a plea to Congress: Regulate us, and quickly
During an extraordinary hearing Tuesday, members of a Senate subcommittee called for aggressive regulation of…
Opinion: Compounding pharmacies offer a fix for shortages of essential drugs
In the early days of the Covid pandemic, gravely ill patients began to fill America’s…
STAT+: FDA advisory panel narrowly recommends approval for Sarepta’s gene therapy for Duchenne
For an archived version of a live blog about Friday’s FDA advisory panel hearing, click…
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Tracking the FDA advisory panel on Sarepta’s gene therapy for Duchenne muscular dystrophy
The Food and Drug Administration is convening a meeting of outside experts on Friday to…
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R.J. Reynolds sues California to protect ‘crisp’ cigarettes from flavor ban
WASHINGTON – Tobacco giant R.J. Reynolds is suing the state of California in an effort…
Listen: Pharma vs. PBMs, Sarepta at the FDA, & a bold idea gone awry
Is there a Bermuda Triangle of drug prices? Do FDA advisers matter? And when should…
STAT+: How the FDA’s pandemic flexibilities boosted mental health apps — and what happens now
In April 2020, the Food and Drug Administration announced a pandemic enforcement policy allowing mental…
STAT+: Telework helps FDA compete for scientists. What if it’s no longer an option?
WASHINGTON — The Food and Drug Administration needs to hire scores of in-demand scientists, and…
Opinion: Three misconceptions about the accelerated drug approval pathway
On Friday, the Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee will…
STAT+: What FDA mandate? Sun Pharma halts shipments from a plant with a troubled history
In a fresh sign of quality-control problems in the Indian pharmaceutical industry, the U.S. Food…
STAT+: What to know about a pivotal FDA hearing on Sarepta’s gene therapy for Duchenne
On Friday, a committee of advisers to the Food and Drug Administration will meet to…
STAT+: ‘Hard to catch up’: FDA commissioner on regulating new digital health tools
WASHINGTON — Digital health tools are developing faster than the Food and Drug Administration is able…
STAT+: 4 ways the health care system should shift its thinking on AI, according to experts
This week, the “Godfather of AI” Geoffrey Hinton made news when he left Google and…
Listen: Lilly’s Alzheimer’s success, a milestone FDA approval, & Moderna’s shrinking business
What’s the future of Alzheimer’s disease treatment? How do you pivot from a pandemic? And…
STAT+: New Eli Lilly Alzheimer’s data poses Medicare coverage conundrum
WASHINGTON — Eli Lilly’s latest anti-amyloid Alzheimer’s treatment seems to slow the disease, the company announced…
FDA approves first RSV vaccine, a long-sought scientific achievement
The Food and Drug Administration on Wednesday licensed the first-ever vaccine for respiratory syncytial virus,…
RJ Reynolds is threatening to sue vape shops for selling flavored vapes
WASHINGTON – The tobacco giant RJ Reynolds is threatening to sue small vape shops if…
Study: Ingredient found in salad bowls and burger wrappers less safe than previously thought
A compostable salad bowl seems like an Earth-friendly way to enjoy a healthy lunch. But…
A research team airs the messy truth about AI in medicine — and gives hospitals a guide to fix it
In public, hospitals rave about artificial intelligence. They trumpet the technology in press releases, plaster…
Telehealth companies that provide abortion pills grapple with regulatory uncertainty
You’re reading the web edition of STAT Health Tech, our guide to how tech is…
STAT+: FDA approves new treatment from Biogen for rare form of ALS
The Food and Drug Administration on Tuesday granted conditional approval to a new treatment for…
STAT+: Sens. Bernie Sanders, Bill Cassidy reach deal on PBM, generic reform
WASHINGTON — Senate health committee leaders Bernie Sanders and Bill Cassidy on Tuesday announced an agreement…
With little FDA oversight, melatonin supplements vary widely in actual dosage, study finds
WASHINGTON — Consumers turning to melatonin gummies to get some help falling asleep might be…
Supreme Court maintains access to abortion pill mifepristone, at least for now
WASHINGTON — The U.S. Supreme Court on Friday ruled 7-2 that a commonly used abortion…
Opinion: Judicial overreach is an immediate hazard to already precarious public health
The United States is in poor health. Life expectancy rates have dropped precipitously, and racial…
FDA’s new plan to study opioids’ effectiveness faces resistance
The Food and Drug Administration’s latest plan to study whether opioids are effective as a…
STAT+: STAT-Harris Poll: Most Americans are worried about RSV
A majority of Americans are concerned about the health threat posed by the respiratory syncytial…
Opinion: RSV vaccine approval should be a top priority for the FDA
The calamity of March 2020 arrived two years later for pediatric units. In the fall…
Opinion: OTC naloxone is a baby step toward making the life-saving medication accessible
In an attempt to make naloxone more accessible amid the massive human toll of the…
Opinion: Where are the guidelines for the production of animals with intentional genomic alterations?
Genetic engineering has the potential to transform how we raise animals for meat and other products, making…
STAT+: A bellwether moment: Once a distant dream, gene therapy for Duchenne nears historic decision
Brent and Sabina Furbee could see something was wrong with their son, Emerson, even if…
Opinion: I’m a biopharma supply chain specialist — and even I can’t find the Adderall I’m prescribed
For 10 years, I have depended on Adderall to help me function. But in February,…
STAT+: Medicare advisers endorse reforms to lower drug spending
In the latest move to address prescription drug pricing, the Medicare Payment Advisory Commission unanimously…
Listen: How the legal battle over abortion could thwart research, plus: the FDA ‘bully pulpit’ and Moderna’s future
Is pharma facing an existential threat? How do you get CEOs to speak out? And…
Opinion: Harvey Washington Wiley campaigned for food and drug safety in the early 20th century. Digital mental health needs its own Wiley moment
Prior to the early 20th century, America had no regulation of medications or food additives….
STAT+: Oracle’s Cerner Enviza launches a new effort to use AI to study asthma drug safety
Cerner Enviza is partnering with health care AI company John Snow Labs to develop artificial…
Opinion: The mifepristone debacle is just the latest blow in an ongoing assault on the FDA’s authority
When legislators tour their home states and districts, private sector leaders often tell them: We…
EPA proposes limits on carcinogenic gas used to sterilize medical devices
On Tuesday, the Environmental Protection Agency proposed new limits on the use of a carcinogenic…
6 burning questions about how the FDA will handle conflicting abortion pill decisions
A dueling pair of federal court decisions has thrown the fate of the abortion pill…
Where is PhRMA in the mifepristone debate?
WASHINGTON — A judge’s decision to suspend the Food and Drug Administration’s approval of an…
FDA warns some Philips respirators may not deliver the right treatment
On Friday, the Food and Drug Administration issued a Class I recall for certain Philips…
Federal judge suspends FDA approval of abortion pill
In a case that could reshape pregnancy in America, a federal judge on Friday sided…
Abbott recalls 4 million glucose monitor readers over risk they can catch fire
Health care giant Abbott has recalled four million readers for glucose monitors after reports that…
STAT+: FDA withdraws approval of controversial drug to prevent preterm births
After a years-long controversy, the U.S. Food and Drug Administration ordered the immediate withdrawal of a…
STAT+: Pharmalittle: FDA slams company recalling eye drops over manufacturing issues; U.S. funds massive Alzheimer’s research database
Good morning, everyone, and welcome to another working week. We hope the weekend respite was…