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Pfizer announced Tuesday that its bivalent respiratory syncytial virus (RSV) vaccine candidate met one of two primary endpoints when administered to pregnant participants to help protect their infants from RSV disease after birth. Read More
Due to a provision in the recently passed Inflation Reduction Act (IRA), Alnylam Pharmaceuticals won’t be conducting a phase 3 trial of its RNAi therapeutic to treat the rare eye condition Stargardt disease. Read More
As part of its commitments under the recently reauthorized Generic Drug User Fee Amendments (GDUFA), the FDA has set out a list of eight science and research priorities for generics for fiscal year 2023 with a focus on impurities and bioequivalence. Read More
AstraZeneca’s blockbuster Fasenra (benralizumab) has stumbled in its quest to become a therapy for eosinophilic esophagitis, failing to hit the clinical target of its dual-primary endpoints in a critical phase 3 trial. Read More
Pharma giant Bayer has won the top spot at the inaugural WCG Innovation Challenge for its efforts to make the charitable donation of unused trial kits and supplies an industrywide practice. Read More