Keeping Track: Recent NDA Submissions Range From Acute Agitation To Von Hippel-Lindau Disease
News and highlights of applications submitted for US FDA approval, from the Pink Sheet’s FDA Performance Tracker
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The MHRA is losing no time in getting its much heralded “new era” of medicines regulation up and running.
Cipla sees an incremental revenue opportunity of up to $500m for its US franchise by fiscal 2025 and expects to propel growth with strong execution of its complex generics pipeline. The company is also beginning to “lay the blueprint” in China and Brazil, it said at the J.P. Morgan Healthcare Conference.
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.