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 ...
Tag: FDA
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 ...
FDA Unveils First 9 Picks for Pilot Program Speeding Up Review of ‘National Priority’ Products
A gene therapy for hearing loss. A drug that helps people quit e-cigarettes or vaping. An anesthetic whose main ingredient ...
FDA approves Zoryve for atopic dermatitis in young children
Credit: Unsplash/CC0 Public Domain The U.S. Food and Drug Administration has approved the supplemental new drug application for Zoryve (roflumilast) ...
NIH, autism, FDA, mifepristone, drug prices: Morning Rounds
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. It’s October, ...
Top FDA regulator’s unusual criticism of therapy gets Wall Street wagging
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and ...
With FDA Nod in Rare Hormone Disease, Crinetics Can Challenge Blockbuster Meds From Novartis, Ipsen
Drugs for the rare hormone disorder acromegaly include older engineered peptides administered as frequent injections. A new FDA approval brings ...
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