US FDA Oncology Applications: Real-Time Review And Breakthrough Pathway Show Durable Appeal
Recent submissions include what could be the fourth novel agent approved under the RTOR pilot.
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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.
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.