Keeping Track: FDA Clears Celltrion's Biosimilar Inflectra; Review Activity In OIC Picks Up
The latest drug development news and highlights from our FDA Performance Tracker.
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Descovy demonstrated noninferiority to Truvada in men and transgender women who have sex with men, but pharmacokinetic data do not support a demonstration of pre-exposure prophylaxis efficacy in cisgender women, US FDA says in advisory committee briefing document.
Amgen, Celgene, Mylan and Gilead were among the companies that provided business updates at the Cowen and Co. Healthcare conference and Raymond James Institutional Investors conference.
Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker