Keeping Track: FDA Clears Celltrion's Biosimilar Inflectra; Review Activity In OIC Picks Up
Executive Summary
The latest drug development news and highlights from our FDA Performance Tracker.
You may also be interested in...
Gilead's Descovy May Have Problem Getting HIV Prevention Indication In Cisgender Women
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.
Investor Conference Business Updates, In Brief
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.
Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck’s V116
As Merck’s 21-valent vaccine approaches its 17 June user fee goal, the US CDC’s vaccine committee is looking at new adult age-based recommendations and bracing for a full pipeline led by GSK’s 24-valent candidate.