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.
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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.
Speedy Approval Of Gilead’s Veklury Sets Stage For Pediatric Expansion, Dosing Refinement
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.
Gilead’s Veklury Approval Shows US FDA’s Existing Regulatory Tools Are Up To The COVID-19 Challenge
The FDA emphasized the rigor of its review of the first COVID-19 therapy, which used few expedited pathways on its way to approval after a two-and-a-half-month review. Post-marketing studies will address remaining concerns about dosing and special populations.
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