FDA flags cholesterol drug for possible effectiveness issues

The Food and Drug Administration has initiated a Class II recall of 141,984 bottles of atorvastatin calcium after tests ...

FDA recalls 580K bottles of this blood pressure medication: Is your medicine on the list?

The U.S. Food and Drug Administration recalled more than 580,000 bottles of a blood pressure medication. Is your medication ...
STAT

Experts worry FDA’s credibility is being shredded by scandal and ‘soap opera’

It was the latest shockwave to sweep through an agency beset by all kinds of tumult in recent months. In interviews, ...

Sydnexis unveils more data for SYD-101 days after FDA refusal

The FDA issued Sydnexis with a complete response letter on 23 October, blocking SYD-101 from entering the US market.

Dr. Oz and FDA chief say biosimilar drug reform will lower prices

Trump administration officials pledged Monday that major reforms for biosimilar drug approvals will expand access and lower ...
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Lawsuit against top FDA drug regulator is packed with incendiary texts, emails

A lawsuit filed against George Tidmarsh, who resigned from a top FDA post on Sunday, includes a series of incendiary texts ...

FDA says drug makers have recalled a blood pressure medicine tainted with a cancer-causing chemical

The U.S. Food and Drug Administration says drug makers have recalled more than a half-million bottles of the blood pressure ...

FDA to ease copycat drug rules, speeding access to cheaper drugs

The U.S. Food and Drug Administration (FDA) announced Wednesday that it will relax certain rules for approving low-cost versions of some high-priced medications, in an effort to speed up access to ...