Drugs
Latest
FDA Policy/General
FDA Commissioner Nominee Overton Gets 9/24 Confirmation Hearing
Biologics
Ultragenyx Gains Approval for Resubmitted Gene Therapy
Biologics
Interchangeable Product Development Strategy Outlined
Drugs
Many FDA-Ordered Postmarket Studies Not Done
Drugs
Sen. Warren Continues to Push for TrumpRx Contracts
Devices
Neptune Medical Robotic Endoscopy Cleared
Drugs
Rescind Filing of 2 Zydus Applications: Gilead
Drugs
FDA Must Correct on Rare Diseases, Not Overcorrect: Column
Drugs
FDA Adds Kybella Warning Over Serious Risks From Off-Label Injections
FDA Policy/General
Senate Looks to Rush Overton’s FDA Head Nomination: Report
Drugs
Prepare for Enhanced FDA/SEC Oversight: Sidley
Drugs
FDA Finalizes Guide on Use of Buffy Coat Blood Processing
Drugs
CGMP Issues at Bausch and Lomb Tampa Facility
Devices
FDA Launches Medical Device Regulatory Reliance Portal
Drugs
FDA Taking Expedited IND Pilot Applications
FDA Policy/General
Cassidy Remains Noncommittal on Overton FDA Nomination After Meeting
Drugs
Bill to Make Pediatric Rare Disease Voucher Permanent
Biologics
FDA Clears Path for Rocket to Complete Pivotal Gene Therapy Trial
Drugs
Psychedelic Drug Hearing Focuses on Access, Safety
Drugs
Enhertu Cuts Progression Risk 37% in Lung Cancer Trial
Drugs