FDA medical reviewers tell the Oncologic Drugs Advisory Committee there are significant questions about Spectrum Pharmaceuticals proposed lung cancer ...
FDA reviewers say that a confirmatory trial has not confirmed the clinical benefit of Oncopeptides Pepaxto (melphalan flufenamide), throwing into ques...
The Alliance for Regenerative Medicine and Pfizer suggest changes to an FDA draft guidance on real-time oncology review.
CDER Office of Generic Drugs associate director Sarah Ibrahim discusses the first-year output of the new Generic Drug Cluster involving several regula...
FDA issues a safety alert on a cybersecurity risk with Medtronics MiniMed 600 Series Insulin Pump System (e.g., MiniMed 630G and MiniMed 670G).
FDA lifts a 12/2021-ordered clinical hold on a Merck IND to permit a new Phase 3 clinical program with once-daily islatravir for treating people with ...
FDA says its inspections in India are nearing pre-pandemic levels.
CDER associate director Theresa Mullin says FDA will soon release a draft guidance on Incorporating Clinical Outcome Assessments into Endpoints for Re...
