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FDA commissioner Marty Makary hands in his resignation after a week of mounting speculation that the Trump Administration was prep...[ Price : $8.95]
Stakeholders ask FDA to clarify its draft guidance on responses to an FDA-483.[ Price : $8.95]
An FDA Federal Register notice requests information from drug developers and academic investigators to support a pilot project foc...[ Price : $8.95]
Ipsen withdraws its cancer drug Tazverik (tazemetostat) from the U.S. market after new clinical trial data showed an increased ris...[ Price : $8.95]
A March inspection of SCA Pharmaceuticals cites multiple manufacturing and contamination-control deficiencies at its outsourcing f...[ Price : $8.95]
FDA seeks public input on ways to expand drug repurposing efforts, aiming to accelerate treatment options for patients with unmet ...[ Price : $8.95]
FDA issues updated guidance for companies developing therapies to treat, prevent or reduce recurrence of Clostridioides difficile ...[ Price : $8.95]
An FDA inspection cites multiple quality control and aseptic processing concerns at Staska Pharmaceuticals.