Praxis Precision Medicines Provides Corporate Update and Reports Third Quarter 2025 Financial Results

Announced positive results from two pivotal Phase 3 Essential3 studies of ulixacaltamide HCl in essential tremor (ET); ...

FDA Issues Complete Response Letter for Biohaven's VYGLXIA (troriluzole) New Drug Application for Spinocerebellar Ataxia

Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range ...
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FDA complete response letter cites issues in Biohaven Vyglxia NDA

Biohaven (BHVN) announced that it has received a complete response letter from the FDA for the new drug application seeking approval of Vyglxia ...
Targeted Oncology

Robust Response by UGN-103 in NMIBC Supports Future NDA Submission

The FDA accepted the investigational new drug application for UGN-103 in April 2024. These new positive data position the ...
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Aquestive Therapeutics Announces Positive Topline PK Results from its Pediatric Study and Completes the NDA Submission for Anaphylm™ (epinephrine) Sublingual Film

Reports positive pharmacokinetic (PK) results from the recently completed pediatric study for Anaphylm™ Completes submission of its New Drug Application (NDA) for Anaphylm to the FDA; NDA acceptance ...

Protagonist Reports Third Quarter 2025 Financial Results and Provides Corporate Update

Following the NDA submission for icotrokinra treatment of adults and adolescents with moderate to severe plaque psoriasis to ...