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STAT+: Blood cancers may arise from CAR-T cells, but experts think only in very rare cases
The announcement on Tuesday that the Food and Drug Administration was investigating whether CAR-T immunotherapy…
Category: FDA
STAT+: Scott Gottlieb, Trump FDA chief, questions whether there’s a Republican philosophy on health care
WASHINGTON — One of the Republican party’s most prominent health care thinkers doesn’t know what…
STAT+: FDA investigating whether CAR-T, a treatment for cancer, can also cause lymphoma
The Food and Drug Administration said Tuesday that it is investigating whether CAR-T therapy, which…
Today’s biotech news roundup, in under 800 words
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Opinion: Manufacturers need to be more open about a dangerous Alzheimer’s drug side effect
Since the FDA’s approval of lecanemab (marketed as Leqembi) and Medicare’s recent decision to cover…
A nonprofit group is pushing to get estrogen FDA approved for gender-affirming care
Hormone replacement therapies have long been approved by the Food and Drug Administration for use…
STAT+: Springworks wins FDA approval for drug to treat desmoid tumors
The Food and Drug Administration on Monday approved the first treatment for people with desmoid…
Medtronic isn’t afraid of Wegovy’s potential to disrupt
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STAT+: Delay of eye drop recall highlights FDA’s impotence on the issue
WASHINGTON — It took nearly three weeks for a maker of eye drops to recall…
Merck cough drug doesn’t pass panel scrutiny
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Opinion: The FDA is at a crossroads on cell and gene therapies
Cell and gene therapies are the next frontier in medicine and promise long-sought hope for…
STAT+: FDA approves Medtronic high blood pressure device despite a negative advisory panel vote
The Food and Drug Administration has approved a Medtronic device to lower blood pressure, the…
The return of biotech’s “bump factor” amid an economic downturn
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STAT+: FDA’s Janet Woodcock to retire early next year
WASHINGTON — Principal Deputy FDA Commissioner Janet Woodcock will retire early next year from the…
STAT+: FDA cites Dr. Reddy’s for quality control problems at a biologics plant
Dr. Reddy’s Laboratories, one of the world’s largest generic drugmakers, was cited by the U.S….
How do we know Alzheimer’s drugs ‘work’?
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FDA grants approval for first time to a home test for chlamydia and gonorrhea
The Food and Drug Administration granted marketing approval to a home test for chlamydia and…
STAT+: More drug and device patents were invalidated for bad info than those filed by other industries, analysis finds
The patents on medicines and devices approved by the U.S. Food and Drug Administration were…
STAT+: FDA’s latest reorganization puts a new emphasis on its investigations
WASHINGTON — There’s about to be a new acronym in town. The Food and Drug…
STAT+: To get things done fast at FDA: ‘Don’t tell anybody,’ cancer chief says
WASHINGTON — The Food and Drug Administration’s top cancer drug regulator doesn’t always ask for…
The first vaccine for the increasingly prevalent chikungunya virus is here
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Opinion: Pulling probiotics from NICUs can put preemies at risk of necrotizing enterocolitis
Maybe probiotics would have saved my son’s life. I’ll never know because when I asked…
STAT+: FDA’s Califf wants to get the public as excited about life expectancy as cures
WASHINGTON — It’s easy to get people worked up about cures, but they don’t seem…
STAT+: FDA’s Woodcock, other experts highlight persistent issues plaguing pharma, biotech in the wake of Covid-19
WASHINGTON — Current and former government officials proffered a clear eyed, and often depressing, take…
Your morning biotech news roundup
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Pulse oximeters’ inaccuracies in darker-skinned people require urgent action, AGs tell FDA
More than two dozen attorneys general are urging Food and Drug Administration officials to take…
Opinion: STAT+: The PATCH Act’s approach to securing medical devices actually gives malicious actors a blueprint
In August 2013, the FDA made news when it issued cybersecurity guidance for medical devices….
STAT+: Data backing prescription digital therapeutics found lacking in rigor, inclusivity
The fast-evolving world of digital therapeutics offers the promise of lowering barriers to accessing health…
Shrinking COVID vaccine sales has Moderna course-correcting
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Novo Nordisk is concluding research on Wegovy’s impact on osteoarthritis
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STAT+: After Sarepta trial failure, families and doctors brace for another debate on Duchenne therapy
To hear Sarepta CEO Doug Ingram tell it, the results Monday afternoon from a large…
STAT+: Pharmalittle: Panel tells FDA that CRISPR sickle cell therapy is safe enough for patients; U.K. is urged to scrap IP demands in trade talks with India
Rise and shine, everyone. The middle of the week is upon us. Have heart, though….
Gene editing has had a big week in the spotlight. Here’s what’s going on
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Opinion: Listen: Sniffing out the power, and limits, of the placebo effect
Have you ever taken phenylephrine for a stuffed-up nose and then felt better? If so,…
Sarepta’s disappointing data put the FDA in a difficult spot
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On the eve of Halloween, the FDA weighs whether medicine should ever taste like candy
WASHINGTON – M&Ms, Reese’s, gummy bears, and even cotton candy made an appearance at the…
Your Monday morning biotech news roundup
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STAT+: FDA has some safety concerns about CRISPR-based sickle cell treatment, documents show
The Food and Drug Administration said on Friday that it has some safety concerns about…
Regeneron gene therapy improves hearing in child
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STAT+: Pharmalittle: Sanofi plans to spin off its consumer health biz; EMA says no evidence GLP-1 drugs linked to thyroid cancer
And so, another working week will soon draw to a close. Not a moment too…
STAT+: FDA approves Lilly ulcerative colitis treatment with a new approach to tamping down inflammation
The Food and Drug Administration on Thursday approved an Eli Lilly drug that takes a…
STAT+: Europe takes steps to head off drug shortages, even as U.S. proposals stall
European drug regulators are updating regulations to stem drug shortages. Are there lessons for Americans?…
Why AstraZeneca’s CEO is accusing British tabloids of ‘fake news’
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Johnson & Johnson antiviral pill for dengue shows early efficacy
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STAT+: After a lull, the pace of FDA authorization of AI-enabled medical devices is rising
The Food and Drug Administration on Thursday released a new accounting of artificial intelligence tools…
STAT+: A 50-year battle over one additive highlights FDA’s challenges with food safety
WASHINGTON — Richard Nixon was the president when the Food and Drug Administration issued its…
Wegovy doesn’t work for everyone, and no one’s quite sure why
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STAT+: FDA’s warning to J&J’s Abiomed signals a crackdown on digital health tools
The Food and Drug Administration is following through on its promise to regulate more health…
STAT+: Better Therapeutics data on apps’ benefit with GLP-1s, Orexo hits a snag
You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology…
STAT+: Peter Marks on creating Operation Warp Speed, but for rare diseases
Peter Marks wants drug developers to ask more stupid questions. It’s part of the top…