House lawmaker raises new concerns over FDA's ultra-fast drug review program

A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten ...

US FDA classifies Abbott's glucose sensor recall as most serious after seven deaths

Feb 4 (Reuters) - The U.S. Food and Drug Administration on Wednesday classified Abbott's recall of certain glucose monitoring ...
Fierce Pharma

Amgen resists FDA request to pull rare disease drug Tavneos from the market

Amgen has denied a request by the FDA to voluntarily withdraw its rare disease drug Tavneos from the market, the company said Tuesday as it presented quarterly financial results.
Fierce Biotech

FDA demands better response from Abbott over Libre inspection violations

Abbott has been hit with a slew of complaints from the FDA in a warning letter related to its continuous glucose monitor (CGM ...
MEAT+POULTRY

FDA considers tightening gluten disclosure rules for packaged foods

The US Food and Drug Administration has issued a Request for Information (RFI) on labeling and preventing cross-contact of ...
MedPage Today on MSN

Mitch McConnell hospitalized; FDA's heart device warning; OTC ivermectin

Health news and commentary gathered by MedPage Today staff ...
BioSpace

Amgen Will Not Heed FDA Request To Withdraw Rare Disease Drug Tavneos

After review, Amgen is certain that Tavneos is effective and has a favorable benefit-risk profile. The company informed the ...
MedPage Today

FDA Removes Warning Page About Dangerous Autism Treatments

The FDA removed a webpage that warned consumers about potentially dangerous products and therapies marketed as autism treatments. An archived version of the page said the agency had warned or taken ...
BioSpace

FDA’s Commissioner’s Priority Voucher Program ‘Shrouded in Secrecy,’ Democratic Rep Says

Rep. Jake Auchincloss of Massachusetts said the Commissioner’s National Priority Voucher program did not receive congressional backing. The FDA has also not yet made disclosures for eight senior ...
Becker's Hospital Review

FDA sounds early alert on Abiomed heart pumps

The FDA has issued an early alert warning of a potentially high-risk issue affecting certain Abiomed heart pumps. The agency said Abiomed issued an urgent medical device correction Jan. 27 for all ...
STAT

Trump administration officials blocked FDA effort to fast-track review of psychedelic treatment

Trump administration officials vetoed the FDA's plan to fast-track the review of a psychedelic treatment for severe ...

AstraZeneca’s Initial Application for Lupus Injection Turned Down by FDA

The company is working with the U.S. regulator to move forward with an updated application, adding a decision is expected in ...