STAT+: Vape makers see Supreme Court ruling as a weapon in fighting FDA
WASHINGTON — Vape manufacturers are taking a victory lap over a Supreme Court decision that…
Category: FDA
Will Medicare finally begin covering weight loss drugs like Zepbound and Wegovy?
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STAT+: Don’t write off MDMA yet: How the FDA got on board with psychedelics
Days after an advisory committee resoundingly voted for the Food and Drug Administration to reject…
Exclusive: European VC Forbion hires Dyne CEO, expands into US
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FDA issues long-awaited draft guidance for enrolling more people of color in clinical trials
The Food and Drug Administration has drafted guidance aimed at getting drug companies and medical…
Intellia says its CRISPR-based therapy can be redosed
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Opinion: FDA: Don’t rush publishing your diversity guidance plan. Take your time and do it right
When Congress passed the Food and Drug Omnibus Reform Act (FDORA) in December 2022, it…
One firm, two conflicting takes on Alnylam’s HELIOS-B
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Opinion: Turning a ‘no’ vote into progress: How to advance MDMA-assisted psychotherapy for PTSD
Many people have interpreted as a setback the “no” vote by an advisory committee to…
The findings from Alnylam’s highly anticipated readout
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Opinion: The FDA needs to embrace phage therapy to help fight antimicrobial resistance
My daughter, Mallory, died in 2017 at the age of 25 from a multiply resistant…
‘We’re failing right now’ in type 2 diabetes, FDA chief says
ORLANDO — The United States is at a critical juncture in its efforts to treat…
STAT+: What the Sarepta decision means for Duchenne patients, the company, and the FDA
Sarepta Therapeutics always wins. That was a given, even before the Food and Drug Administration…
STAT+: Top FDA official Peter Marks overruled staff, review team to approve Sarepta gene therapy
For a third time, Sarepta Therapeutics has convinced a top Food and Drug Administration official…
STAT+: FDA approves Sarepta’s Duchenne gene therapy for nearly all patients
The Food and Drug Administration on Thursday approved Elevidys, Sarepta’s gene therapy for Duchenne muscular…
STAT+: Pharmalittle: We’re reading about Lilly lawsuits, Novo Nordisk fires and much more
Rise and shine, everyone, another hot day is on the way. The forecast – at…
Lilly takes more actions against unapproved versions of Mounjaro
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STAT+: Republican lawmakers criticize FDA’s partnership with CHAI on regulating AI in medicine
Republican lawmakers are sharply criticizing the Food and Drug Administration’s relationship with a nonprofit group…
STAT+: Former medical device CEO who sold fake plastic parts sentenced to 6 years in prison
The former CEO of Stimwave, a company that sold pain-relief devices with dummy pieces of…
New Merck pneumococcal vaccine wins FDA approval
The Food and Drug Administration on Monday approved Merck’s new pneumococcal vaccine for adults 18…
FDA offers new guidelines for Covid-19 vaccine
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J.P. Morgan has officially jumped into early stage biotech investing
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STAT+: FDA gets pointed input on ‘optimizing’ advisory committee panels
The day an FDA advisory committee met to weigh the merits of an experimental treatment…
Listen: Duchenne gene therapy setback, Alzheimer’s drug endorsement & why a STAT reporter buys weed (for journalism)
On this week’s episode of “The Readout LOUD,” our STAT colleague Nicholas Florko joins us…
Biopharma execs cheer Supreme Court for upholding FDA authority in abortion pill case
On Thursday, the Supreme Court rejected an effort by anti-abortion doctors to bar the mailing…
Supreme Court unanimously rejects challenge to mailed abortion pills
The Supreme Court ruled unanimously that anti-abortion doctors did not have standing to challenge the…
With Avidity and Pfizer, gene therapy enters a phase
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Senators slam the FDA’s new vape enforcement plan: ‘What in the hell have you been waiting for?’
WASHINGTON — The Food and Drug Administration and the Department of Justice claim they’re getting…
FDA says it’s getting serious about illegal vapes. It’s still likely to get a tongue lashing.
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and…
Eli Lilly’s Alzheimer’s candidate, Bob Langer’s new startup, and other biotech news you need to know
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STAT+: The inside story of how Lykos’ MDMA research went awry
At a heated advisory committee meeting convened by the Food and Drug Administration last week,…
FDA expands approval for GSK’s RSV vaccine to cover younger at-risk adults
The Food and Drug Administration on Friday expanded the approval for GSK’s vaccine to protect…
Vanda Pharmaceuticals has another suitor
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Listen: Psychedelics at the FDA, ASCO recap, & MorphoSys update
How did advisers react to the first psychedelic therapy to go before the Food and…
Novovax will be able to supply Covid-19 vaccines this fall
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STAT+: Psychedelics companies see FDA panel’s vote as a growth opportunity, not a roadblock
A day after a panel of advisers to the Food and Drug Administration expressed deep…
Testing begins for a new form of PrEP
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STAT+: Tracking the FDA advisory panel on MDMA therapy for PTSD
Good morning, and welcome to STAT’s live blog of the Food and Drug Administration’s scientific…
Can AstraZeneca make good on its promise?
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STAT+: ASCO 2024: FDA oncology head wants clinical trials to range beyond China alone
CHICAGO — The Food and Drug Administration’s top oncologist reiterated that the agency doesn’t want drugmakers…
What to watch for in the crucial FDA meeting on MDMA therapy for PTSD
In less than three months, the Food and Drug Administration will decide whether to approve…
The surprising outperformance of a new drug against existing competitors, and other biotech updates
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Drug treatment that insists on abstinence? Federal agencies are just saying no
For as long as the federal government has worked to support substance use treatment, it…
Biohaven’s autoimmune drug disappoints, and other biotech news updates from the week
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What the rescheduling of marijuana might — and might not — mean for scientific research
WASHINGTON — After years of inertia, the field of research into the health effects of…
STAT+: Clinical lab trade group sues FDA over plan to regulate lab-developed tests
A group representing clinical labs across the country sued the Food and Drug Administration on…
Wegovy linked to lower risk of alcohol use disorder in real-world study
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Biotech’s most interesting fundraisings from the last week
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More tumult at BIO amid the company’s fourth CEO in four years
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STAT+: After MDMA therapy, she considered suicide. The trial data tell a different story
The MDMA study was her last hope. She had read headlines celebrating a 83% response…