Keeping Track: Chiesi Breathes Easier With Bronchitol Approval; Submissions Aplenty From GSK, Pfizer, AZ, AbbVie
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Pfizer Embraces Biotech-Like Speed To Advance BCMA Bispecific
Chris Boshoff, Pfizer Oncology chief development officer, said lessons from the rapid pace of the company’s COVID-19 vaccine program are being applied to elranatamab and other cancer therapies.
Astellas' Phase III Front-Line AML Study Of Xospata Fails
One expert said the company should focus efforts on developing the drug for maintenance treatment of AML.
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.