News FDA turns down Hetlioz for jet lag once again Vanda will continue to push for approval of Hetlioz for jet lag, despite the FDA saying its trial designs were not satisfactory.
News No Christmas present for Sanofi, as FDA turns down MS drug FDA has turned down Sanofi's oral BTK inhibitor tolebrutinib for multiple sclerosis, despite suggesting earlier it would delay a decision until 2026.
R&D FDA’s emerging framework to reduce animal testing: Implicati... Exploring the strategic shift toward reducing reliance on non-human primates (NHPs) and other animal species in R&D.
News MSD claims two national priority vouchers; report The next two discretionary priority vouchers to be awarded by the FDA are reported to be heading for two MSD drug candidates.
News Antibiotic is first approval in FDA national priority scheme FDA approves its first 'national priority' drug – a version of the widely used antibiotic Augmentin XR – in double-quick time.
News FDA set to raise bar for clinical trials of CAR-T therapies The FDA could make it harder for developers of CAR-T therapies to bring them to market by requiring full randomised controlled trials.
News Repligen builds in cell therapy with $1.5bn BioLife takeover Repligen has reached a deal to buy cell therapy specialist BioLife Solutions for $1.5bn, tapping into a market growing at breakneck speed.
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