Keeping Track: Mycovia Vivjoa, BMS Camzyos Approvals Bring FDA’s 2022 Novel Drug Tally To 12
US FDA closed out the month of April with two new molecular entity approvals that address underserved markets but carry some safety concerns.
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The European Medicines Agency’s CHMP was set to adopt opinions on SK Bioscience’s COVID-19 vaccine and Mycovia/Gedeon’s Vivjoa for vulvovaginal candidiasis during its September meeting, but both marketing authorization filings were voluntarily withdrawn.
Working with US FDA was key to developing clinical trials in the absence of regulatory precedents in recurrent vulvovaginal candidiasis, Scynexis VP tells the Pink Sheet; exposure profiles drove different trial designs for Scynexis’ Brexafemme and Mycovia’s just-launched Vivjoa.
Keeping Track: Pediatric Approvals, Seres Starts C Diff Submission, And BMS Pulls Reblozyl sBLA Before Possible CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker