FDA warns Orlando, FL-based Active Cosmetics Manufacturing about CGMP violations in its production of finished drugs.
The U.S. Supreme Court issues a temporary pause on a 5/1 lower court ruling that would have curtailed access to the abortion pill mifepristone.
An opinion article notes that recent FDA regulatory decisions are leading to a sharper focus on the evidentiary standards underpinning cell and gene t...
FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a consumer-facing Web site for its drug Amvuttra.
FDA issues an untitled letter to Bayer HealthCare Pharmaceuticals, citing misleading direct-to-consumer advertising for its prostate cancer drug Nubeq...
FDA commissioner Marty Makary outlines his goals to overhaul how the agency reviews new drugs, aiming to reduce early-stage regulatory friction, accel...
New Bloomberg reporting that FDA is facing mounting internal strain and external criticism just over a year into commissioner Marty Makarys tenure.
Clene says it plans to submit an NDA in the third quarter for its experimental amyotrophic lateral sclerosis therapy.
