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Opiant Pharmaceuticals Announces Completion of Rolling NDA Submission for OPNT003, Nasal Nalmefene, for Opioid Overdose

SANTA MONICA, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals (LLTPD), Inc. (“Opiant”) (NASDAQ: OPNT) today announced it has completed submission of its rolling New Drug Application ...
Nasdaq

Ocuphire Completes Last Clinical Trial Supporting the Planned 2022 NDA Submission with the Announcement of Positive Results from MIRA-4 Pediatric Safety Trial Evaluating Nyxol ...

Nyxol Demonstrated a Favorable Safety Profile and Rapidly Reversed Dilated Eyes in Pediatric Subjects 3 to 11 Years Old, Consistent with Findings in MIRA-2 and MIRA-3 Phase 3 Registration Trials ...
Business Wire

Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug ...
Nasdaq

Medexus Pharmaceuticals Announces Resubmission of Treosulfan NDA

Additional data collection and analysis reconfirms confidence in New Drug Application for TreosulfanNDA resubmission date consistent with previously announced timelineFDA decision still expected ...
Seeking Alpha

Ardelyx Announces FDA Advisory Committee Meeting to Review XPHOZAH® NDA Tentatively Scheduled for November 16, 2022

WALTHAM, Mass. , June 21, 2022 /PRNewswire/ -- Ardelyx, Inc. (ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that ...