STAT+: Ellis Unger, an outspoken FDA veteran, resigns
WASHINGTON — A top FDA official known for speaking out against controversial drug approval decisions,…
Category: FDA
STAT+: Congress presses the FDA to move faster on ALS drugs
WASHINGTON — Lawmakers pressed a top Food and Drug Administration official Thursday for answers on…
What happened to the FDA’s toughest regulator?
You’re reading the web edition of D.C. Diagnosis, STAT’s weekly newsletter about the politics and…
Opinion: On compounding, the FDA marches to the beat of its own biases
The FDA’s approval of the drug Aduhelm as a treatment for Alzheimer’s disease — despite…
FDA chief Janet Woodcock acknowledges agency may have misstepped in process leading up to Alzheimer’s drug approval
WASHINGTON — Acting Food and Drug Administration Commissioner Janet Woodcock acknowledged on Wednesday her agency…
Powerful House Democrats demand documents from Biogen about coordination with FDA on new Alzheimer’s drug
WASHINGTON — Two powerful House Democrats on Monday demanded documents from Biogen about the approval…
Experts warn full Covid-19 vaccine approval is no quick fix for hesitancy
WASHINGTON — The Food and Drug Administration issuing full approval for two Covid-19 vaccines might…
FDA calls for federal investigation into its controversial Alzheimer’s drug approval
The head of the Food and Drug Administration has called for a wide-ranging federal investigation…
STAT+: FDA’s expansive Alzheimer’s drug approval surprised even top agency officials
WASHINGTON — The Food and Drug Administration’s contentious decision to approve a new Alzheimer’s drug…
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STAT+: FDA, under fire from critics, revises prescribing information for Biogen’s Alzheimer’s drug
The Food and Drug Administration on Thursday changed the prescribing label for Biogen’s Alzheimer’s treatment…
Newly disclosed FDA documents reveal agency’s unprecedented path to approving Aduhelm
Chastened after a decisively negative review from outside advisers, the Food and Drug Administration convened…
Third member of FDA expert committee resigns over controversial Alzheimer’s therapy decision
A third member of a Food and Drug Administration expert panel has resigned over the…
Member of FDA’s expert panel resigns over controversial Alzheimer’s therapy approval
Following the Food and Drug Administration’s polarizing authorization of the Alzheimer’s therapy Aduhelm on Monday,…
STAT+: Fibrogen admits false heart-safety data for experimental anemia pill shared with FDA, investors
Fibrogen acknowledged Tuesday that the company has been touting false heart-safety data for its experimental…
STAT+: FDA cites lack of evidence in rejecting Acadia Pharma’s bid to expand use of anti-psychosis drug
Acadia Pharmaceuticals said Monday that U.S. regulators had rejected its application seeking to expand the…
STAT+: A ‘conditional’ EUA for a CytoDyn Covid treatment? FDA says no such thing exists
Speaking Monday night to investors on a conference call, CytoDyn CEO Nader Pourhassan said the…
STAT+: Is a leaderless FDA clamping down on drug reviews? Not knowing is weighing heavy on biotech
Seemingly overnight, the Food and Drug Administration appears to be taking a more risk-averse stance…
STAT+: A surprise FDA advisory panel imperils Fibrogen’s experimental anemia pill
Fibrogen was expecting the Food and Drug Administration to complete a review of its experimental…
Sarepta wins new drug approval for patients with Duchenne muscular dystrophy, its third marketed treatment
The Food and Drug Administration on Thursday approved a new medicine from Sarepta Therapeutics that…
STAT+ Conversations: The D.C. Diagnosis
Each week, STAT Plus subscribers get exclusive access to live discussions with STAT reporters and…
STAT Plus: Biomarin, Gilead drug rejections don’t signal a change in attitude at the FDA
It’s tempting to interpret the Food and Drug Administration’s surprise rejections of drugs from Gilead…
STAT Plus: Applied Therapeutics’ muted response to a clinical hold speaks volumes
How a company communicates with investors can be just as meaningful as what it communicates….
STAT Plus: FDA refuses application for HIV drug from CytoDyn, raising more questions about its credibility
The Food and Drug Administration refused to accept an application seeking the approval of a…
STAT Plus: Zogenix wins approval for new drug to treat rare type of childhood epilepsy
A new drug from Zogenix that treats a rare and severe type of epilepsy was…
STAT Plus: CytoDyn says lead HIV drug was not filed for FDA approval, as previously claimed
CytoDyn CEO Nader Pourhassan is already under fire for the timing of lucrative sales of…
STAT Plus: Bristol’s MS drug approval is good news for shareholders but patients will have to wait
A new multiple sclerosis medicine from Bristol Myers Squibb (BMY) was approved Thursday by the…