Keeping Track: Resubmissions For Tlando And Twirla NDAs, And A BTD For Pomalyst
The latest drug development news and highlights from our US FDA Performance Tracker.
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Keeping Track Of User Fee Decisions And Filings: Adakveo, Brukinsa And Fetroja Mark Massive Week Of Novel Approvals
The latest news on US FDA user fee decisions and submissions to the agency.
Agile's Twirla Suffers Scathing Critique By US FDA Ahead Of Advisory Cmte.
Agile's transdermal contraceptive will go before the Bone, Reproductive and Urologic Drugs Advisory Committee as it nears the end of its third review cycle, although the agency appears ready to issue another complete response letter before it even hears from the panel.
Finance Watch: Q1 Numbers Suggest A Brisk VC Deal Pace For Cell And Gene Therapies In 2019
An Alliance for Regenerative Medicine (ARM) report shows big Q1 numbers for venture capital and partnership deals. Also, mid-May VC deals surge globally across therapeutic areas, Biogen pushes back against a bargain-hunting investor and recent public company financings.