After losing 3,500 employees in April—19% of its workforce due to congressional budget cuts—the FDA is now struggling to meet drug approval deadlines. The latest example is its failure to rule on Bayer’s menopause treatment, elinzanetant. More: Another FDA mini-pause
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CHMP recommends authorization for LP.8.1-targeting vaccine ahead of 2025-2026 season More: Moderna’s updated COVID-19 vaccine receives positive EMA opinion Source: News
read moreA new campaign invites people to chew over the idea of becoming stem cell donors—literally. More: Labcorp sticks up for stem cell donations by joining Gift of Life ‘Hero Gum’ campaign Source: fierce
read moreThe deal will clear all claims brought against the companies and affiliated parties by end purchasers in the multidistrict generics pricing antitrust litigation that is playing out in a Pennsylvania court. More: Sun Pharma, Taro agree to 0M settlement in
read moreFour months after giving Eli Lilly’s Alzheimer’s disease treatment Kisunla a thumbs-down, Europe’s CHMP has recommended it for approval, albeit in a restricted patient population. The regulator also backed Gilead’s breakthrough PrEP drug Yeytuo. More: Europe's CHMP gives thumbs-up to
read moreModerna has scrapped plans to build an mRNA plant in Japan. Otsuka and Lundbeck’s proposal for Rexulti as part of a PTSD treatment was rejected by an FDA advisory committee. Pfizer’s PD-1xVEGF deal with 3SBio includes an option agreement. And
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