FDA approves Fennec Pharmaceuticals Pedmark to treat cisplatin-associated ototoxicity in pediatric patients.
Federal Register notice: FDA announces an 11/22 Oncologic Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Zejula (n...
FDA approves a Guerbet NDA for Elucirem (gadopiclenol), a new macrocyclic gadolinium-based contrast agent for use in contrast-enhanced magnetic resona...
FDA issues contract manufacturer Catalent a 12-item Form FDA-483 over GMP concerns found during a recent inspection at the firms Bloomington, IN facil...
FDA clears a Medtronic 510(k) for its LINQ II Insertable Cardiac Monitor system for expanded use in pediatric patients over the age of two years who h...
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CDER associate director Theresa Mullin says FDA will soon release a draft guidance on Incorporating Clinical Outcome Assessments into Endpoints for Re...
