April US FDA Approval Decisions To Cover Cardiomyopathy, CNS And China-Developed Cancer Drugs

The user fee goal dates for Junshi Biosciences/Immorna Joint Venture/Coherus BioSciences, Inc.’s PD-1 inhibitor toripalimab and HUTCHMED (China) Limited’s angio-immuno kinase inhibitor surufatinib bookend the month of April, providing the US FDA more chances to define its stance on the recent wave of oncology applications based on Chinese trial data.

In between toripalimab’s 1 April and surufatinib’s 30 April 2022 user fee dates are the FDA decision goal dates for three more novel agents: orphan indications in cardiology (Bristol Myers Squibb Company’s mavacamten, 28 April) and neurology (Alnylam Pharmaceuticals Inc.’s vutrisiran, 14 April) and the BLA for Regeneron Pharmaceuticals, Inc