Keeping Track: GSK’s Priorix Makes Three Novel US FDA CBER Approvals In 2022; Two CV Drugs Among Recent NDAs
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Gene Therapies: US FDA Has Used Accelerated Approval Four Times Based On Intermediate Clinical Endpoints
Three of the accelerated approvals were for CAR-T products, a class that the agency considers to be gene therapies. The FDA’s September approval of bluebird bio’s Skysona for cerebral adrenoleukodystrophy was the lone non-cancer product in the group. Pink Sheet infographic tracks the required confirmatory studies and timelines for all four products.
Investigational products from Minoryx and a host of other companies targeting a range of diseases are now under review by the European Medicines Agency for potential EU approval.
Shuttle Pharmaceuticals and PaxMedica launch two small initial public offerings in the US as the market awaits a significant IPO. Also, Assertio closed a $70m follow-on offering, Codiak restructures and cuts jobs, and Vilya emerges with $50m in series A venture capital.