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Latest From Scynexis, Inc.
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
US FDA closed out the month of April with two new molecular entity approvals that address underserved markets but carry some safety concerns.
Public Company Edition: Blackstone Life Sciences Yield will finance approved products, while the firm’s prior fund supports late-stage programs. Also, Coeptis will merge with a SPAC, Bausch + Lomb secured post-IPO debt, and BioXcel revealed a $260m financing and new subsidiary.