Biohaven (BHVN) announced that it has received a complete response letter from the FDA for the new drug application seeking approval of Vyglxia ...
Comprehensive meeting with FDA conducted in Q3 in conjunction with Breakthrough Therapy DesignationKey aspects of a potential NDA application ...
The FDA accepted the investigational new drug application for UGN-103 in April 2024. These new positive data position the ...
Following the NDA submission for icotrokinra treatment of adults and adolescents with moderate to severe plaque psoriasis to ...
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 ...
Kazia Therapeutics Limited ('Kazia' or the 'Company') today announced its intention to request and hold a follow-up Type C meeting with the U.S. Food & Drug Administration (FDA) to discuss overall ...
No treatment-related discontinuations were reported. Reproxalap has now been studied in over 2,500 patients. The potential NDA resubmission is anticipated in 2024, with the review period expected to ...
3don MSN
Achieve Life Sciences outlines expedited FDA review for cytisinicline and targets Q3/Q4 2026 launch
Discover key Q3 2025 insights from Achieve Life Sciences as they expedite cytisinicline’s FDA approval for nicotine dependence.
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