TransCelerate reports on a 2025 tabletop exercise it convened with the CDER Center for Clinical Trial Innovation that focused on streamlined safety da...
New reporting reveals that FDA has withdrawn or blocked the publication of multiple internal studies supporting the safety of Covid-19 and shingles va...
FDA warns Orlando, FL-based Active Cosmetics Manufacturing about CGMP violations in its production of finished drugs.
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.
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.
