RAPS

FDA Signs Off on Par Pharma's Bioequivalence Study on Generic Wellbutrin Even as Questions Remain

The US Food and Drug Administration (FDA) has approved a supplemental Abbreviated New Drug Application (sNDA) sponsored by Par Pharmaceuticals for a 300 mg, extended-release version of the popular ...
Monthly Prescribing Reference

FDA Signs Off on New Version of Abortion Pill Mifepristone

The latest approval adds another generic option to the market, but it's not expected to change access in states where abortion is still restricted or banned. HealthDay News — A new low-cost version of ...
RAPS

This Week at FDA: ACIP signs off on bivalent boosters

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The biggest ...
Hosted on MSN

Beam soars 22% as FDA signs off on its ambitious gene-editing plan

Beam stock launched to a 10-month high Monday after the company reached a deal with the Food and Drug Administration for its gene-editing drug, BEAM-302. Beam TherapeuticsBEAM is testing its drug in ...
UPI

FDA signs off on new COVID vaccines but limits who will get them

Aug. 27 (UPI) --The federal government signed-off on the latest round of COVID-19 vaccines, but new limits were set on which Americans can get them after U.S. Health and Human Services Secretary ...