FDA ACCEPTS NEW DRUG APPLICATION FOR CELECOR'S INVESTIGATIONAL HEART-ATTACK DRUG

The U.S. Food and Drug Administration has accepted CeleCor Therapeutics' New Drug Application (NDA) for zalunfiban (DisaggproTM) and assigned a target action date of June 18, 2027 under the ...
Healio

FDA accepts new drug application for ralinepag in PAH

Please provide your email address to receive an email when new articles are posted on . The new drug application included data from the phase 3 ADVANCES OUTCOMES trial. The Prescription Drug User Fee ...
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Gossamer Bio Submits New Drug Application to U.S. FDA for Seralutinib for the Treatment of Pulmonary Arterial Hypertension

– NDA Supported by the Phase 3 PROSERA Study, Phase 2 TORREY Study and Additional Supportive Analyses – ...
Business Insider

Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate

Resubmission of NDA includes Chemistry, Manufacturing, and Controls (CMC) data from a new drug product manufacturing vendor The resubmission package includes 12 months of OLC drug product stability ...
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FDA accepts new drug application for dual-mechanism glaucoma drop

Please provide your email address to receive an email when new articles are posted on . K-911, also known as NCX 470, uses nitric oxide and bimatoprost to lower IOP through two distinct outflow ...