Novel Drug Approvals for 2023
Each year, CDER approves a wide range of new drugs and biological products.
List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents…
FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma
FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma
Drug Trials Snapshots: DATROWAY
Drug Trials Snapshots: DATROWAY
Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment
Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment
State Importation Program Enhancements
FDA is committed to continuing to work with states and Indian tribes that seek to develop an importation proposal under…
Healwell Homeo Private Limited – 706206 – 06/12/2025
CGMP/Finished Pharmaceuticals/Adulterated
“Peter Michael, M.D. – 711299 – 06/18/2025
Clinical Investigator
www.buynetmeds.com – 706335 – 06/12/2025
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
Staska Pharmaceuticals, Inc. – 699291 – 05/05/2025
Compounding Pharmacy/Adulterated Drug Products