Announced positive results from two pivotal Phase 3 Essential3 studies of ulixacaltamide HCl in essential tremor (ET); ...
Comprehensive meeting with FDA conducted in Q3 in conjunction with Breakthrough Therapy DesignationKey aspects of a potential NDA application ...
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 ...
Biohaven (BHVN) announced that it has received a complete response letter from the FDA for the new drug application seeking approval of Vyglxia ...
The FDA accepted the investigational new drug application for UGN-103 in April 2024. These new positive data position the ...
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 ...
The outcomes of a successful pre-NDA meeting with the FDA are: As agreed with the FDA, the rolling NDA submission will commence in December 2025, targeting a complete NDA submission in early 2026 and ...
CHARLOTTE, N.C., Feb. 20, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (CHTP) today announced that it has received written guidance from the Director of the Office of New Drugs ...
Following the NDA submission for icotrokinra treatment of adults and adolescents with moderate to severe plaque psoriasis to ...
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