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Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling

Endo, Inc. (OTCQX: NDOI) (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously…

A Meta‐Analysis of International Flunixin Pharmacokinetics in Horses: Toward Regulatory Harmonization and Individualized Detection Times Using Bayesian Paradigm

A meta-analysis of flunixin concentrations in 65 horses from four countries estimated pharmacokinetic parameters. Considering the estimated plasma-to-urine ratio, raising…

FDA approves revumenib for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation

On October 24, 2025, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed…

Expanded Access | Information for Institutional Review Boards (IRBs)

Learn more about what IRBs should consider when reviewing Individual Patient Expanded Access Requests.

Expanded Access | Information for Industry

Expanded Access information for medical product companies and other industry stakeholders

Expanded Access | Information for Physicians

Expanded Access: Physicians’ Page

Expanded Access (Compassionate Use) Submission Data

Expanded Access (Compassionate Use) Submission Data

SPARTAN may be harmful due to hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use SPARTAN, a product promoted and sold for…

FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma

On October 23, 2025, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody…

2024 First Generic Drug Approvals

2024 First Generic Drug Approvals