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
You may also be interested in...
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.
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.
Japan approves a batch of new products and indications, including Daiichi Sankyo's Enhertu in a high-need indication after a rapid review and Takeda's Zejula, which will be made available to selected patients before its reimbursement listing.