Keeping Track: Approvals For Addyi, Adcetris; Merck Bulks Up Keytruda Filings
The latest drug development news and highlights from our FDA Performance Tracker.
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Sponsor’s claimed impact on exercise tolerance was not adequately supported and should not serve as a marketing advantage for the chronic obstructive pulmonary disease drug, FDA review staff said. However, Boehringer Ingelheim’s failed attempt for the exercise-related labeling language spurred the agency to clarify the types of studies and endpoints that potentially could support such claims.
CDC’s universal recommendation for XBB COVID vaccines means that Novavax’s protein-based vaccine can enter the market immediately upon FDA authorization, but some final questions from the agency are keeping the review going.
FDA approval was swiftly followed by CDC advisory committee recommendation of the XBB.1.5. variant-based vaccines for all people aged 6 months and older.