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The CDER Office of Surveillance and Epidemiology annual report says it contributed to 55 novel drug and therapeutic biologic appro...[ Price : $8.95]
FDA accepts for review a Vertex Pharmaceuticals NDA for suzetrigine, a selective NaV1.8 pain signal inhibitor for treating moderat...[ Price : $8.95]
Federal Register notice: FDA releases fiscal year 2025 rates for generic drug user fees.[ Price : $8.95]
FDA clears a Varian 510(k) for its IntelliBlate microwave ablation system, intended for ablating soft tissue.[ Price : $8.95]
Federal Register notice: FDA renews its Pharmacy Compounding Advisory Committee for an additional two years.[ Price : $8.95]
Federal Register notice: FDA withdraws approval of 23 ANDAs from multiple applicants after they notified the agency that the produ...[ Price : $8.95]
AstraZeneca says data from its Phase 3 AMPLIFY trial showed that Calquence (acalabrutinib) in combination with venetoclax showed f...[ Price : $8.95]
FDA cites a Kaleo social media post about Auvi-Q (epinephrine injection) because it presented benefit information but failed to in...