STAT+: Pharma’s losing bet in New Jersey
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and…
Category: FDA
Maryland takes first steps to cap drug costs
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Blackstone wants in on red-hot immunology market
The need-to-know this morning Biogen and Ionis Pharmaceuticals are ending their development of an experimental drug for ALS based on…
Leqembi gets closer to being offered as an injection
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My rendezvous with the raw milk black market: quick, easy, and unchecked by the FDA
WASHINGTON — It’s Friday May 10, and I’m on my way to what feels like…
Is Novavax a new meme stock?
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USDA, FDA turf battles hamper responses to outbreaks like H5N1 bird flu
WASHINGTON — On a bright June day in 2018, one of the nation’s top regulators…
STAT+: Cue Health’s Covid-19 tests could give false results, FDA warns
The Food and Drug Administration warned consumers Monday to not use Cue Health’s at-home Covid-19…
We now know Tome’s gene editing target
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STAT+: FDA is criticized for taking a ‘ministerial’ role in sorting out some pharma patents
When it comes to a crucial controversy over pharmaceutical patents, the FDA has been MIA….
The public wants Medicare to cover obesity drugs
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STAT+: CDC goes hard on military pets
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and…
Yet another big financing round in immunology
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Opinion: H5N1 communication has been strictly for the birds. Didn’t the federal government learn anything from Covid?
When it comes to federal agencies communicating to the public about H5N1 bird flu, it…
STAT+: Software glitch caused Tandem insulin pumps to prematurely shut down, FDA warns
At least 224 diabetes patients have been harmed by a software error causing their insulin…
Pharma has over $500B in capital for deals
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Vertex starts gene therapy Casgevy in five patients
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ICER casts doubt on Sarepta’s DMD gene therapy
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Pasteurization inactivates H5N1 bird flu in milk, new FDA and academic studies confirm
Extensive testing of pasteurized commercially purchased milk and other dairy products from 38 states has…
The latest government crackdowns on biotech you need to know
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FDA wants to hear your thoughts on advisory committees
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STAT+: FDA finalizes plan to regulate some lab-developed tests
The Food and Drug Administration will start actively regulating tests developed in laboratories, with some…
There’s never a good time to drink raw milk. But now’s a really bad time as bird flu infects cows
Scientists who know about the types of pathogens — E. coli and Salmonella among them…
Biden administration punts menthol cigarette rule indefinitely
WASHINGTON — The Biden administration is walking away from a plan to permanently bar menthol cigarettes,…
STAT+: Day One drug for common childhood brain tumor approved by FDA
Day One Biopharmaceuticals said Tuesday the Food and Drug Administration approved its pill for one…
Opinion: Bashing accelerated approval isn’t supported by the data
The Food and Drug Administration’s accelerated approval program aims to speed “approval of drugs that…
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Opinion: STAT+: Use evidence to support early coverage of gene therapy after accelerated approval
Gene editing and therapy to replace missing or defective genes is one of the most…
Opinion: An FDA pathway can accelerate innovation for Duchenne muscular dystrophy
In human biology, the protein dystrophin is a shining example of Joni Mitchell’s classic line,…
Opinion: STAT+: How AI can help satisfy FDA’s drug, device diversity requirements
The Food and Drug Omnibus Reform Act of 2022 (FDORA), which was passed as part…
STAT+: Grocers are pushing legislation they claim would enhance food safety. Advocates say it would gut FDA rules
WASHINGTON – In the last decade, Americans have been sickened by salmonella from cucumbers, listeria…
Philips, maker of millions of defective sleep apnea machines, ordered to overhaul manufacturing
WASHINGTON — The company responsible for a global recall of sleep apnea machines will be barred…
STAT+: Device made by company J&J is buying for $13 billion clears hurdle in independent study
A fully independent clinical trial researchers thought might disprove a cardiac device made by Shockwave…
STAT+: About half of cancer drugs given accelerated approval don’t improve survival or quality of life
SAN DIEGO — For decades, the Food and Drug Administration’s accelerated approval pathway has helped…
STAT+: DNA test that predicts opioid addiction should be pulled off the market, critics urge the FDA
In the next 24 hours, more than 130 people will die from opioid-related drug overdoses….
STAT+: FDA approves TriClip for tricuspid heart valve disease, pitting Abbott against Edwards
The Food and Drug Administration approved a new device from Abbott meant to treat tricuspid…
Lawmakers want to add more Chinese biotechs to defense list
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STAT+: FDA clears digital stethoscope company’s AI algorithm for heart failure
An AI algorithm to detect heart failure, embedded in a digital stethoscope, earned clearance from…
STAT+: This AI company scans penis pictures for STIs. Its unproven tech is in an FDA gray zone
Artificial intelligence is already assessing decay in your teeth, abnormalities in your heart rhythm, and…
STAT+: Otsuka’s digital treatment for depression cleared by FDA, as pharma tries to crack tricky market
The Food and Drug Administration has cleared Otsuka Pharmaceutical’s digital treatment for major depressive disorder,…
Aardvark Therapeutics gearing up for $200 million IPO
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What’s Congress going to do with WuXi?
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Who can sue the FDA? Answering Justice Alito’s question from the mifepristone arguments
WASHINGTON — Supreme Court Justice Samuel Alito had a clear question at Tuesday’s arguments over…
Does decaf coffee contain a harmful additive? Advocates want to ban a certain chemical in the brew
WASHINGTON — There’s a fight brewing over the future of decaf coffee. Consumer health advocates…
Brazil’s plan for low-cost CAR-Ts
New biotech newsletter launching tomorrow. Don’t miss out. Good morning, everyone. Damian here with the…
STAT+: FDA is still struggling to inspect clinical research sites, watchdog finds
The U.S. Food and Drug Administration’s oversight of clinical research in hospitals and clinics has…
Supreme Court mifepristone arguments focus on physicians’ right to sue, not FDA judgment
WASHINGTON — Supreme Court justices on Tuesday seemed to question physician’s right to sue the…
How will the Supreme Court’s mifepristone decision impact biopharma?
New biotech newsletter launching this Thursday. Don’t miss out. Hey there. Today, we discuss the…
SCOTUS’ abortion pill mifepristone case is really about the FDA
WASHINGTON — The Supreme Court on Tuesday will hear opening arguments in an abortion medication…
STAT+: Patient advocates clash over wisdom of ‘approving drugs faster and faster’
NEW YORK — Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress…
FDA approves new drug to protect immune compromised from Covid-19
The Food and Drug Administration on Friday authorized a new antibody to protect immunocompromised individuals…