Generic Competition and Drug Prices
FDA report demonstrating greater competition among generic drug makers can lead to lower generic drug prices.
Identification of Metabolites for the Novel 5α‐Reductase Inhibitor Epristeride In Vitro and Its Potential Impact on Doping Testing
Epristeride, a novel noncompetitive inhibitor of Type II 5α-reductase, was studied for its metabolic profile in vitro using HLMs and LC-HRMS,…
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
FDA approves first interchangeable biosimilar to Perjeta to treat certain types of breast cancer
FDA approves first interchangeable biosimilar to Perjeta to treat certain types of breast cancer.
Electronic Submissions Presentations
List Electronic Submissions Presentations
FDA approves new interchangeable biosimilar to Perjeta
On November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable…
FDA approves ziftomenib for relapsed or refractory acute myeloid leukemia with a NPM1 mutation
On November 13, 2025, the Food and Drug Administration approved ziftomenib (Komzifti, Kura Oncology, Inc.).
Drug Development Considerations for the Treatment of Neonatal Enterovirus Infection and Congenital Cytomegalovirus Infection–Virtual Public Workshop – 05/07/2024
The Food and Drug Administration is holding a public, two-day workshop entitled Development of Drugs for the Treatment of Congenital…
Taizhou Kangping Medical Science and Technology Co., Ltd. – 711081 – 10/09/2025
CGMP/Finished Pharmaceuticals/Adulterated
IBSPOT.com Inc. – 715657 – 10/27/2025
Unapproved New Drugs/Misbranded