US pandemic preparedness got a boost with the Center for Biologics Evaluation and Research’s approval of Seqirus’ Audenz, a pandemic influenza A (H5N1) vaccine destined for the national stockpile, while Trevena Inc. tried to chip away at another issue of national significance – the opioid crisis – with the resubmission of its novel IV opioid for acute pain, oliceridine.
Keeping Track: Seqirus Pandemic Flu Vaccine Approved; Trevena Resubmits Oliceridine
The latest drug development news and highlights from our US FDA Performance Tracker.
More from US FDA Performance Tracker
• By
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
• By
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
• By
The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
• By
The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.