Court rules Juul can temporarily keep selling e-cigarettes while it prepares challenge to FDA ban
WASHINGTON – Juul’s e-cigarettes won’t be pulled off the shelves just yet. A federal court…
Category: FDA
The Biden administration wants to get tough on states’ abortion pill restrictions. It won’t be easy
WASHINGTON — Attorney General Merrick Garland is hinting he’s ready to get tough on states…
FDA orders Juul e-cigarettes off the market in the U.S.
WASHINGTON — The Food and Drug Administration has ordered all vaping products made by the…
STAT+: Despite fanfare, the FDA’s step toward lowering nicotine levels in cigarettes is a very early one
WASHINGTON — When the Food and Drug Administration said Tuesday it would eventually lower the…
The Senate health committee finally marks up its user fee bill
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and…
Opinion: ‘Pink tape’ at the FDA is delaying access to contraception — again
As the crisis over access to reproductive health deepens in the U.S., the Food and…
STAT+: Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals
WASHINGTON — The Senate is taking pains to avoid another Aduhelm controversy. In new bipartisan…
A no good, very bad week for the FDA
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and…
STAT+: The FDA says it’s in the dark about thousands of dietary supplement ingredients
WASHINGTON — The companies that make dietary supplements like vitamins and herbs have quietly introduced…
As Congress takes up FDA oversight of dietary supplements, a lobbying showdown looms
You’re reading the web edition of D.C. Diagnosis, STAT’s weekly newsletter about the politics and…
STAT+: Senate FDA legislation will include dietary supplement, cosmetic reforms
WASHINGTON – Senate lawmakers are set to unveil draft legislation as soon as Monday that…
STAT+: Congress moves toward reforming FDA accelerated approvals, but with pharma-friendly concessions
WASHINGTON — House lawmakers are moving a little closer toward cracking down on drug makers…
The FDA’s Rob Califf on importing drugs from Canada, on Aduhelm, and on opioids
You’re reading the web edition of D.C. Diagnosis, STAT’s weekly newsletter about the politics and…
STAT+: UnitedHealthcare restricts coverage of Aduhelm, following Medicare
UnitedHealthcare is restricting insurance coverage of Aduhelm across all of its health plans, saying the…
STAT+: Medicare’s Brooks-LaSure expects restrictions on accelerated approval drugs, like those for Aduhelm, to be ‘very rare’
AUSTIN, Texas – Chiquita Brooks-LaSure, the head of Medicare, said on Thursday that the agency…
STAT+: The revolving door swings again as Lupin hires an FDA official who oversaw problems at a key plant
The revolving door between the U.S. Food and Drug Administration and the pharmaceutical industry turned…
The FDA’s ban on menthol in cigarettes clears a major regulatory hurdle
D.C. Diagnosis is STAT’s weekly newsletter about the politics and policy of health and medicine….
STAT+: Right to try 2.0: Advocates want to reduce oversight of ‘n of 1’ therapies
WASHINGTON — The libertarian think tank behind the federal “right-to-try” law is back at it…
STAT+: CDC, FDA, and NIH staffers aren’t reporting political interference, new watchdog report shows
WASHINGTON — Staff at the nation’s health agencies suspect political interference is inappropriately influencing government…
Opinion: Will the shadow of Aduhelm cloud FDA’s decision-making on an ALS therapy?
On March 30, an FDA advisory panel voted 6 to 4 against recommending approval of…
The next battle in the never-ending war over Aduhelm
You’re reading the web edition of D.C. Diagnosis, STAT’s weekly newsletter about the politics and…
Faced with high drug prices, seniors are abandoning cancer drugs at the pharmacy
The pressure on Medicare just keeps ramping up Medicare is set to decide this month…
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Califf admits the FDA’s Alzheimer’s drug decision impacted experts’ trust in the agency
WASHINGTON — Robert Califf, the new head of the Food and Drug Administration, admitted Thursday…
STAT+: An ALS therapy sets up a crucial test of the FDA’s independence
WASHINGTON — A high-profile, experimental therapy for ALS is teeing up a crucial test of…
Opinion: Welcome back, Dr. Califf: Patients will see you now
The confirmation of Robert Califf to lead the Food and Drug Administration is among the…
STAT+: Lawmakers face off about the future of the FDA’s accelerated approval pathway
WASHINGTON – Lawmakers are facing off over the future of the Food and Drug Administration’s…
STAT+: Congress moves toward giving FDA authority over synthetic nicotine products like Puff Bar
WASHINGTON — Lawmakers are within striking distance of closing the largest loophole in the Food…
Covid budget crunch looms over government funding fight
You’re reading the web edition of D.C. Diagnosis, STAT’s weekly newsletter about the politics and…
STAT+: Key Democrat moves to crack down on FDA accelerated approvals
WASHINGTON – A powerful Democratic lawmaker has introduced a bill that would dramatically rein in…
The FDA’s promised menthol ban is about to face a critical test
You’re reading the web edition of D.C. Diagnosis, STAT’s weekly newsletter about the politics and…
Opinion: Containing Covid-19 requires rapid tests that are highly sensitive to infections. Why is the FDA asking for something different?
With rapid testing becoming a key tool in the fight against Covid-19, in a mid-October…
STAT+: FDA’s vaccines and biologics chief talks Covid-19, 2022 priorities, and getting back to gene, cell therapy review
WASHINGTON — No part of the Food and Drug Administration has been challenged by the…
STAT+: 3 contentious decisions the FDA will make in 2022
WASHINGTON — It’s going to be a bumpy 2022 for the Food and Drug Administration….
STAT+: Pharmalittle: Moderna says booster shot raises antibody levels to thwart Omicron; Sanofi buys yet another biotech
Rise and shine, everyone, another busy day is on the way. Although it may feel…
Covid antivirals could be pandemic game-changers. But Americans might struggle to access them
Antiviral drugs for treating Covid-19 have been hailed as a pandemic “game-changer” — a tool…
FDA approves first drug for genetic cause of dwarfism
The Food and Drug Administration approved the first treatment for the most common cause of…
STAT+: Could Robert Califf’s ties to tech complicate his FDA nomination?
WASHINGTON — Robert Califf spent his first confirmation hearing explaining his entanglements with the drug…
STAT+: Democratic senators raise concerns with potential FDA pick
WASHINGTON — Sens. Joe Manchin and Richard Blumenthal have concerns with President Biden’s rumored nominee…
STAT+: Biogen’s Aduhelm sales fall dramatically below Wall Street’s expectations
Biogen made just $300,000 from the Alzheimer’s disease treatment Aduhelm in the first full quarter…
Elizabeth Warren on over-the-counter hearing aids, health lobbying, and the FDA’s independence
WASHINGTON — On Tuesday the Food and Drug Administration took a major step toward allowing…
STAT+: Is Robert Califf a savvy choice to helm the FDA — again?
WASHINGTON — The Food and Drug Administration has been without a permanent leader for 10…
STAT+: In its search for a new FDA commissioner, the White House is relying on insiders for advice
WASHINGTON — Ten months into his tenure, President Biden has yet to nominate anyone to…
STAT+: Biogen, Eisai seek fast approval for second Alzheimer’s drug, relying on relaxed FDA standard
Biogen and its Japanese partner Eisai announced Monday evening the start of an application process…
Scott Gottlieb: Trump’s shadow FDA commissioner during Covid-19?
You’re reading the web edition of D.C. Diagnosis, STAT’s weekly newsletter about the politics and…
STAT+: Facing pressure from ALS patients and advocates, the FDA does about-face on review of potential treatment
The Food and Drug Administration has reversed an internal decision and will now review an…
STAT+: FDA dings Kaleido Biosciences for testing a microbiome drug without proper paperwork
The Food and Drug Administration is warning Lexington, Mass.-based Kaleido Biosciences that it shouldn’t have…
Congress demands documents from FDA on controversial approval of Biogen’s Alzheimer’s drug
WASHINGTON — Lawmakers have requested data and documents from the Food and Drug Administration related…
STAT+: Two top FDA officials in charge of Covid-19 vaccines to leave agency this fall
WASHINGTON — The two officials in charge of leading the FDA’s review of coronavirus vaccine…
STAT+: FDA, drug makers propose new pilots aimed at speeding rare disease drugs, as part of user fee update
WASHINGTON — The Food and Drug Administration and the drug industry have jointly agreed to…
Opinion: FDA’s kratom ban would harm the public and damage the agency’s credibility
Trust in the U.S. Food and Drug Administration (FDA) declined after its approval of the…