Mycovia Pharmaceuticals, Inc.
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Latest From Mycovia Pharmaceuticals, Inc.
Keeping Track: US FDA Approval Binge Includes Brexafemme, Wegovy, Ryplazim, Truseltiq, Lybalvi, Tembexa
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Public Company Edition: Initial public offerings may take a holiday break, but 2020 already has been a remarkable year for IPOs in the US and China. Also, Arvinas led the latest follow-ons with a $400m offering followed by TG Therapeutics with a $275m stock sale.
Oteseconazole prevented recurrent VVC in two Phase III studies but Phase III data in acute treatment of VVC episodes in women with RVVC, also due this month, are needed to file for US FDA approval in the first half of 2021.
The US FDA heard a lot about the structural, medical and especially financial barriers facing coccidioidomycosis, or Valley fever, drug development soon after the agency refused to qualify the rare fungal infection for priority review voucher incentives.