Bridget Silverman
Senior Editor
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Latest From Bridget Silverman
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.
Keeping Track: Regeneron Ebola Antibody Cocktail Inmazeb Approved; Avenue Feels Pain From CRL; Scynexis Submits Oral Antifungal
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Keeping Track: Kadmon Chooses RTOR For Belumosudil; NDAs For Novel Imaging Agents And Liquid Anticonvulsants
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Keeping Track Of Breakthroughs: AZ Farxiga, ImmunoGen ADC For Hematologic Cancer, Inventiva NASH Candidate Earn Designation
The latest breakthrough therapy designation news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Keeping Track: Disappointment For Mesoblast And Aquestive; Opdivo/Yervoy Add Mesothelioma Claim; Pediatric Approvals
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.