EU adviser says Illumina merger was not problematic
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Category: FDA
Novo is building a really big computer
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Contineum Therapeutics files for IPO
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STAT+: FDA advisers back CAR-T therapies in blood cancer, despite safety concerns
A panel of expert advisers to the Food and Drug Administration on Friday voted in…
What happens when an approved drug doesn’t work?
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STAT+: Madrigal wins first U.S. approval for drug to treat liver disease MASH
The Food and Drug Administration on Thursday approved the first medicine developed specifically to treat…
Delta 8 THC use reported by 11% of high school seniors
WASHINGTON — In the last year, an estimated 11% of high school seniors have used…
Preventing the weaponization of AI-designed proteins
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STAT+: Amylyx ALS drug failure leaves patients, advocates, and researchers reeling — and wondering what’s next
The latest disappointment in amyotrophic lateral sclerosis research brought crushing news for patients and physicians,…
STAT+: Obesity drug Wegovy gets FDA approval to add cardiovascular benefits on its label
U.S. regulators approved a label expansion for Novo Nordisk’s obesity drug Wegovy to tout its…
STAT+: In stunning outcome, Amylyx’s ALS drug fails large clinical trial
Amylyx Pharmaceuticals said Friday that its treatment for ALS, called Relyvrio, failed to provide any…
STAT+: FDA clears first over-the-counter continuous glucose monitor
For the first time, anyone in the United States will soon be able to buy…
FDA advisory panel recommends a streamlined flu vaccine for next fall
When Americans line up for flu vaccines next fall, they will almost certainly be getting…
STAT+: Federal regulators, scrambling to keep up with AI in health care, team up with industry to set standards
At first glance, the Coalition for Health AI looks like any technology lobbying group. Its…
STAT+: Medical device lobby says it’s tired of waiting on Medicare to cover breakthrough devices
Medical technology lobby AdvaMed is fed up with the Centers for Medicare and Medicaid Services….
STAT+: Pharmalittle: We’re reading about Congress punts PBM reform, another obesity drug and more
Rise and shine, everyone, another busy day is on the way. Sadly, gray skies are…
GSK pill works in uncomplicated gonorrhea
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Protocols originally intended to be extra conservative are now heralded as evidence of mifepristone’s risk
Decisions made by the Food and Drug Administration more than 20 years ago have come…
The FDA isn’t afraid to yank a disappointing drug
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What do CEOs owe the world?
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STAT+: FDA gives a mixed response to a petition seeking greater clinical trial transparency
The U.S. Food and Drug Administration told an advocacy group that it is not planning…
Colorado could cap payments for Amgen’s Enbrel
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and…
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STAT+: FDA warns medical device makers about rise in fabricated data
An increasing number of medical device companies are submitting fabricated and unreliable data, the Food…
STAT+: In ‘major milestone,’ FDA approves first cell therapy for solid tumors
Nearly four decades after its first conception, the first TIL therapy, an immunotherapy that harvests…
Alnylam thickened the plot
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STAT+: FDA cracks down on websites that claim to sell chemicals in obesity drugs Wegovy, Zepbound
The Food and Drug Administration is cracking down on websites that claim to sell the…
STAT+: FDA advisory panel votes in favor of Abbott’s new heart device
An advisory panel to the Food and Drug Administration voted in favor of a new…
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Opinion: What STAT readers think about Aduhelm, CTE and the Super Bowl, and more
STAT now publishes selected Letters to the Editor received in response to First Opinion essays…
STAT+: Major generic maker Aurobindo cuts production at a key plant amid concerns over shortages
Aurobindo, which is one of the largest generic drug makers, has halted some production at…
Opinion: Former U.S. surgeons general: The U.S. should ban menthol cigarettes
As former U.S. surgeons general, we call on the Biden administration to immediately finalize Food…
STAT+: A looming cancer vaccine test for Gritstone Bio, and pushback about Novartis-MorphoSys
This week, I address pushback I received on my Novartis-MorphoSys column. But first, a preview…
Opinion: Aduhelm was a mess — and it could happen again
Last week, Biogen announced it will cease both the study and sale of Aduhelm, its…
Opinion: The Philips CPAP nightmare exposes shortcomings in medical device regulation
Millions of Americans’ bedtime routine includes wearing a mask attached to a respiratory machine that…
Medical devices with screens aren’t accessible to the blind. Congress has chance to change that
Katie Keim was diagnosed with type 1 diabetes in 1967 when she was eight, well…
FDA urged to move faster to fix pulse oximeters for darker-skinned patients
The Food and Drug Administration should move more quickly to ensure pulse oximeters — the…
Opinion: Medicare has different standards than the FDA. That’s how it should be
Who among us is looking forward to getting older in 2024? Not senators (most of…
Listen: Vertex’s polarizing data, Aduhelm’s adieu, & an FDA icon
What makes a blockbuster? Can biotech learn from Aduhelm? And how do you replace a…
Opinion: Where do we go from here on digital therapeutics?
South Korea is the only country to officially recognize digital therapeutics as a category. Nevertheless,…
STAT+: Experts critique flawed system for monitoring drugs’ side effects in wake of asthma drug report
After a drug enters the market, it’s up to Food and Drug Administration regulators to…
Philips to stop selling sleep apnea machines in U.S. under tentative agreement with FDA, DOJ
WASHINGTON (AP) — The company behind a global recall of sleep apnea machines said Monday…
How an immunological Trojan horse could treat disease
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STAT+: FDA’s Woodcock reflects on more than 30 years at agency — and hints at what’s next
WASHINGTON — It’s the end of an era for the Food and Drug Administration’s longtime…
Supreme Court slates abortion pill case for March
WASHINGTON — The Supreme Court will hear arguments about access to the abortion medication mifepristone…
23andMe breach targeted Chinese, Jewish populations
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STAT+: FDA OKs — but doesn’t require — a non-cancer-causing chemical for sterilizing devices
The chemical used to sterilize half of all medical devices in the United States is…
Investigators fault Lilly plant for manufacturing issues
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Opinion: STAT+: Some countries are moving to digital prescription drug information for patients. The U.S. shouldn’t follow suit
Getting a new prescription can be overwhelming: medication schedules, foods to eat or avoid, interactions…
Opinion: The FDA and FTC need to crack down on TikTok and Instagram influencers pitching prescription drugs
In June, the Food and Drug Administration issued a warning letter about advertisements for the…
STAT+: FDA sets aggressive deadline for inspection overhaul
WASHINGTON — Food and Drug Administration officials hope to finish this year a massive overhaul…
STAT+: The FDA’s diagnostics chief, who led through Covid, has retired
Timothy Stenzel, the federal regulator who led the Food and Drug Administration’s diagnostics division during…