STAT+: Most cardiovascular devices with serious safety recalls aren’t tested in patients
When someone’s heart doesn’t beat quite right, an implantable defibrillator can save their life. The…
Category: FDA
STAT+: How efforts to cancel medical debt could wind up benefitting hospitals
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and…
FDA is taking on tampons and ‘misleading’ ads starring Serena Williams
Good morning! I’ve decided today is the day that I must tell you about my…
STAT+: FDA commissioner: Health systems have to ‘step up’ on AI regulation or will ‘end up holding the bag’
WELLESLEY, Mass. — Amid heated discussions on how artificial intelligence should be regulated and who…
STAT+: ‘Sarepta’s like a curse on me’: FDA commissioner dismisses controversy over approval
WELLESLEY, Mass. — At an event with journalists Tuesday outside of Boston, U.S. Food and…
Key lawmakers are wary of giving FDA more cash to crack down on e-cigs
WASHINGTON – Powerful House lawmakers from both parties are skeptical of the Food and Drug…
Opinion: In drug development, diversity must be extended to preclinical research
The pharmaceutical industry has long operated on a one-size-fits-all model, developing drugs primarily tested on,…
STAT+: Congressional probe questions clinical trials run in China, citing Army involvement
A House committee is investigating whether brand drug companies are collaborating with the Chinese military…
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Carbon Health founder steps back from top role, Kaiser hospitals roll out AI scribe
You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology…
STAT+: Q&A: How the FDA could use AI for drug and device safety surveillance
The Food and Drug Administration’s responsibilities don’t end when a drug hits the market after…
Opinion: Improving the FDA-EMA parallel scientific advice program to advance complex generics
Off-patent medicines provide people with access to high-quality essential treatment options that can be significantly…
STAT+: Another suit filed against FDA over lab-developed test rule
A group representing molecular pathologists sued the Food and Drug Administration on Monday over its…
STAT+: Rick Doblin, ‘unleashed,’ blasts FDA over Lykos drug rejection and turns to global push for MDMA therapy
It’s been a hard week for the psychedelics pioneer Rick Doblin. First, the Food and…
Opinion: First Opinion readers on Noah Lyles and Covid-19, the dearth of geriatricians, PBMs, and more
First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences…
Clinical trials exclude disabled Americans because federal agencies failed them, new report finds
People with disabilities are largely excluded from clinical trials that could benefit them because federal…
STAT+: Gilead wins U.S. approval for drug to treat autoimmune liver disease
The Food and Drug Administration on Wednesday approved a new treatment for primary biliary cholangitis,…
The politics of mifepristone in the 2024 election
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and…
STAT+: Meet the billionaire media mogul who’s taking on the food industry
WASHINGTON — The idea for Todd Wagner’s new advocacy organization FoodFight USA, he says, came…
Opinion: Getting to ‘Plan B’ for psychedelic medicine: Lessons from reproductive health
The Food and Drug Administration’s decision not to approve Lykos Therapeutics’ application for MDMA (a…
DO NOT PUBLISH: FDA rejects MDMA as a psychedelic treatment for PTSD
The Food and Drug Administration rejected MDMA as a treatment for post-traumatic stress disorder on…
FDA approves EpiPen alternative, a nasal spray for anaphylaxis
On Friday, the Food and Drug Administration approved the first needle-free treatment for adults and…
MDMA therapy is facing an imminent FDA decision. Here’s what you need to know
A decades-long campaign to legalize MDMA as a mainstream medical treatment will reach a climax…
STAT+: AI app claiming to diagnose STIs from penis pictures shut down after FTC scrutiny
The company that claimed its AI model could identify sexually transmitted infections from a single…
FDA approves Purdue Pharma’s controversial new overdose-reversal medication
Purdue Pharma, the company best known for fueling the opioid crisis by misleadingly marketing the…
STAT+: Medicare finalizes reimbursement rule for breakthrough medical devices
The Centers for Medicare and Medicaid Services has finalized its rule easing reimbursement for medical…
FDA’s digital health advisory committee takes shape, and a critique of cost-effectiveness studies
You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology…
Opinion: Rising rates of skin cancer: The cost of FDA’s inaction on novel sunscreen products
A decade after Sen. Jack Reed (D-R.I.) authored the Sunscreen Innovation Act, which became law…
STAT+: 7 key people who could shape Trump’s health care policy
WASHINGTON — A second Trump administration would bring a new wave of health policy officials…
Listen: UnitedHealth’s doctor empire, an FDA departure, and Viking’s obesity moves
What makes UnitedHealth similar to Standard Oil? Is Viking Therapeutics an attractive acquisition target? And…
Opinion: Adding psychotherapy to drug therapy works, but the FDA may not be able to handle it
Many people were stunned when an FDA advisory committee voted “no” on a new drug…
Jeff Shuren, medical devices head at FDA, to leave the agency
Jeffrey Shuren, longtime chief regulator of medical devices at the Food and Drug Administration, announced…
Opinion: Fixing the reimbursement and coverage divide between ‘breakthrough’ drugs and medical devices
The Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation…
STAT+: FDA investigators have not spoken with patients and others alleging misconduct in MDMA trials
At a contentious advisory committee meeting in June, the Food and Drug Administration announced it…
‘Legal’ psychedelic mushrooms actually contain illegal hallucinogens, study shows
WASHINGTON – A new study published Thursday finds that several mushroom candies, which are widely…
STAT+: Applesauce lead contamination could not have been prevented, top FDA officials says
CHICAGO – The FDA’s top food regulator contended Tuesday that the agency could not have…
Roche looks to have a competitive GLP-1 drug
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What are the odds we get an heir to Paxlovid?
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STAT+: Top FDA officials weighing regulation of ultra-processed foods, internal documents show
WASHINGTON – Top Food and Drug Administration officials met multiple times earlier this year to…
Element Biosciences raises another massive round
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CAR-T therapy’s complications, as well as its benefits, become clearer in ‘flurry’ of cancer studies
Researchers were perplexed when the Food and Drug Administration announced it was investigating whether CAR-T…
Can you get satiety with GLP-1s without the nausea?
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uniQure shares soar on Huntington’s data
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Lilly’s obesity drug looks more potent than Novo’s in observational study
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The biotech news you missed this week
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Opinion: My stalled relay race to get access to ALS drugs in development
One night in November 2018, I fell while crossing a street in Subic Bay, a…
STAT+: Top Biden administration officials withdraw from Coalition for Health AI
Top Biden administration officials have withdrawn from an industry body formed to set safety standards…
Supreme Court to weigh whether the FDA was heavy-handed with flavored e-cigarette products
WASHINGTON — The Supreme Court took up an e-cigarette case Tuesday, weighing whether the Food…
STAT+: How controversial was the decision by FDA’s Peter Marks to approve Sarepta’s gene therapy? Check its footnotes
The unilateral decision by Peter Marks, a top official at the Food and Drug Administration,…
STAT+: Supreme Court’s gutting of Chevron doctrine could mean headaches for drug industry
The Food and Drug Administration’s power to make important regulatory decisions is in question after…
Opinion: What readers have to say about long Covid, FDA and diversity, and more
First Opinion is STAT’s platform for interesting, illuminating, and maybe even provocative articles about the…