Drugs
Latest
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
Lytenava OK Offers Lessons on FDA’s Use of Confirmatory Evidence
FDA Policy/General
FDA Seeks Input on Statistical Flexibility in Rare Disease Trials
Biologics
Scholar Rock’s Spinal Muscular Atrophy Therapy Approved
FDA Policy/General
FDA Needs Workforce Rebuilding, Less Political Interference: Sinha
Drugs
Etcamah Misses Endpoint in First-Line Breast Cancer Trial
Drugs
FDA Oncology Chief to Focus on AI, Streamlined Drug Development
Oncology Center of Excellence (OCE) director Angelo de Claro says the center will build on initiatives established under longtime and former OCE chief Richard Pazdur while using artificial intelligence (AI) and other approaches to streamline cancer-drug development and increase U.S. participation in clinical trials. Pazdur spent decades overseeing
Drugs
Group Calls for Policy Changes to Sustain Generic, Biosimilar Competition
FDA Policy/General
FDA-SEC Info Sharing Raises Disclosure, Insider Trading Concerns
Drugs
Exelixis NDA Review Extended for Colorectal Cancer Drug
Drugs
Pharming Group’s Joenja Gets Expanded Approval
FDA has granted Pharming Group expanded approval for Joenja (leniolisib) tablets for treating activated phosphoinositide 3-kinase delta syndrome (APDS) in children 4-11 years who weigh at least 27 kg. Joenja was first approved in 2023 for the same indication in patients 12 years and older at a dose
Drugs
Reduced Application Fees Not Sufficient Incentive: Column
FDA’s PDUFA 8 proposal to cut application fees by 50% for qualified drugs to conduct Phase I development in the U.S. is unlikely to achieve that intended result. That’s the opinion of Ovid Therapeutics executive chairman Jeremy Levin. Writing in a BioSpace opinion post, Levin says that
Drugs
Bill to Update FDA Drug Preclusion Rules
Rep. Diana Harshbarger (R-TN) has introduced the Dietary Supplement Innovation Act that she says would modernize FDA’s drug preclusion provision to establish regulatory certainty, ensure pharmaceutical innovation, and support consumer access to dietary supplements. In a statement (includes a link to the bill text and to a brief