Keeping Track: Pfizer, AstraZeneca Get Complete Responses; FDA Sees Breakthroughs In Live Biotherapeutics
Executive Summary
The latest drug development news and highlights from our FDA Performance Tracker.
You may also be interested in...
AstraZeneca Diabetes Combo Needs More Clinical Data, FDA Says
Even though both components are already marketed, firm might have to do another study for fixed-dose combination of DPP-4 inhibitor saxagliptin and SGLT2 inhibitor dapagliflozin.
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
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.