Category - New Drug Applications
Blueprint Medicines Announces FDA Intent to Split Avapritinib New Drug Application into Separate Submissions for PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST
Foamix Announces FDA Acceptance of its New Drug Application for FMX103 Minocycline Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea
Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Management of Postoperative Pain
MC2 Therapeutics Announces Submission of NDA for Wynzora Cream (Calcipotriene 0.005% and Betamethasone Dipropionate 0.064%) for Treatment of Plaque Psoriasis
Zogenix Resubmits New Drug Application for Fintepla for the Treatment of Dravet Syndrome to U.S. Food and Drug Administration
Acacia Pharma Announces New Barhemsys PDUFA Target Date
Sarepta Therapeutics Receives Complete Response Letter from the US Food and Drug Administration for Golodirsen New Drug Application
Cassiopea Announces FDA Submission of New Drug Application for Clascoterone Cream 1%