Potential Positives. Chimerix has submitted a New Drug Application (NDA) for dordaviprone, seeking accelerated approval from the FDA, which is a significant step towards bringing the treatment to ...

Novo Nordisk NOVO.B0.00%increase; green up pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense ...

Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June 4 approval goal date, advancing approval of the drug in the U.S. PharmaTher said it is ...

--Grace Therapeutics, Inc., a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant ...

FDA Clearance of Investigational New Drug Application Received for Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418. PR Newswire. SHANGHAI and SAN DIEGO, May 22, 2025.

The supplemental new drug application was based on results from the phase 3 ARANOTE trial presented at the 2024 ESMO Congress in September. Findings from the trial demonstrated that compared with ...

Zai Lab Announces Acceptance of New Drug Application for KarXT for the Treatment of Schizophrenia. January 17, 2025 07:30 AM Eastern Standard Time. SHANGHAI & CAMBRIDGE, Mass.-- ...

UroGen Announces FDA Acceptance of its New Drug Application for UGN-102. PDUFA goal date set for June 13, 2025 UGN-102 would be the first FDA-approved medicine for LG-IR-NMIBC, if approved ...

Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray Provided by Business Wire Jan 27, 2025 5:01am.

The FDA issued a complete response letter for the resubmission of the reproxalap new drug application for the treatment of signs and symptoms of dry eye disease, according to a press release from ...

Novo Nordisk said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense race to get an oral weight-loss medication on ...