STAT

Beyond detection: In the age of clinical AI, what counts as an FDA ‘breakthrough’ medical device?

Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the impacts of digital health care for patients, providers, and businesses. You can ...
Fox Business

90,000 bottles of children's ibuprofen recalled nationwide, FDA says

Nearly 90,000 bottles of children’s ibuprofen have been recalled over the potential presence of a foreign substance, according to the Food and Drug Administration. Strides Pharma, Inc., headquartered ...
RAPS

FDA drafts guidance on animal testing alternatives

The US Food and Drug Administration (FDA) has released draft guidance aimed at assisting pharmaceutical manufacturers in transitioning from animal studies to non-animal alternatives for drug ...
MedPage Today

So Long, MAUDE? FDA Launches New Combined Adverse Event Database

The FDA has launched a new adverse event reporting system that will consolidate several systems it has for reporting different types of adverse events, the agency announced Wednesday. The new system, ...
NBC News

FDA approves new use of synthetic vitamin B9 — but not for autism symptoms

The Food and Drug Administration on Tuesday announced a new approved use for the drug leucovorin, a synthetic form of vitamin B9 that the Trump administration has touted as a treatment for autism ...
FiercePharma

FDA unveils 4th revision of draft guidance for looser biosimilar testing requirements

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. with a fresh draft guidance proposing more changes to streamline development of the cheaper biologic copies.
Wall Street Journal

Vinay Prasad Is Out at the FDA—Again

Homeland Security Secretary Kristi Noem is out, as Donald Trump names Markwayne Mullin to replace her. Will the DHS personnel change also affect ICE policy? Plus, does the U.S. have enough air-defense ...
CNBC

FDA reversals leave investors worrying about the fates of other experimental drugs

The FDA in the past year has denied or discouraged applications of at least eight new drugs, according to RTW Investments. The agency initially refused to review Moderna's flu shot before reversing ...
CNN

FDA proposes new system for approving customized drugs and therapies for rare diseases

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the ...
The Hill

FDA reverses course, will review Moderna’s mRNA flu vaccine candidate

The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA flu vaccine candidate after holding a high-priority meeting with the company.
Scientific American

FDA agrees to review Moderna mRNA flu vaccine in dramatic reversal

The U.S. Food and Drug Administration will review a messenger RNA (mRNA) flu vaccine for approval, according to its maker, Moderna. The decision is a dramatic U-turn for the agency, which, only about ...
STAT

FDA refuses to review Moderna’s influenza vaccine

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on ...