FDA reviewers didn’t get to vote on first priority voucher drug
WASHINGTON — The Food and Drug Administration has promised companies that earn a Commissioner’s National Priority Voucher a one- to two-month ...
Tag: FDA
Bayer Lung Cancer Drug Lands Speedy FDA Nod to Stay Competitive With a Boehringer Ingelheim Med
A Bayer drug designed to target tumors driven by a rare genetic mutation now has accelerated FDA approval, providing another ...
FDA lifts major warnings on hormone replacement therapy
The U.S. Food and Drug Administration (FDA) is eliminating the prominent "black box" warnings on many hormone replacement therapy (HRT) ...
FDA Will Remove Warnings for HRT Products Used for Menopause
The Food and Drug Administration will remove black box warnings from hormone replacement therapy (HRT) products, which are often used ...
FDA Adds 6 More Meds to Pilot Program for Speedy Review of Drugs in the National Interest
Two obesity drugs are among the six new medications that could get faster FDA review under a new pilot program ...
New FDA priority review vouchers go to Lilly, Novo, Vertex
WASHINGTON — The Food and Drug Administration on Thursday announced the second batch of companies being granted a “Commissioner’s National Priority ...
The NFL, the Q-Collar, and the need for more FDA transparency
The Q-Collar — a neck collar inspired by the woodpecker — has been worn by NFL players and thousands of young ...
Liver Complications Lead FDA to Stop Tests of Intellia Gene-Editing Therapy for a Rare Disease
The FDA has halted clinical testing of an Intellia Therapeutics gene-editing therapy following a report that a patient in a ...
FDA Proposes Dropping Clinical Trial Requirements to Bring Biosimilars to Market More Quickly
The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic ...
STAT+: FDA moves to ease path for biosimilars as Trump seeks to cut drug costs
WASHINGTON — The Trump administration announced a draft framework Wednesday that officials say will speed cheaper versions of biologic drugs ...
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