PLAINSBORO, N.J., May 2, 2025 /PRNewswire/ -- Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational ...
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FDA accepts Cogent’s drug filing for treatment of rare blood disorder
Cogent Biosciences Inc. (NASDAQ:COGT) said the U.S. Food and Drug Administration has accepted its New Drug Application for ...
Sesh Products US, Inc. (Sesh) today announced that the U.S. Food and Drug Administration (FDA) has determined that its bundled Premarket Tobacco Product Application (PMTA) submission, covering 64 SKUs ...
CEO Richard Adcock used a presentation at the Citizens Life Sciences Conference to outline the company’s commercial progress ...
Alumis said its drug, envudeucitinib, met all primary and secondary endpoints in two Phase 3 trials in patients with moderate-to-severe plaque psoriasis. About 65% of patients achieved near-complete ...
MIRA trial data demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo (p < 0.001) at week 12. VELA-1 met all primary and key secondary endpoints with statistical significance ...
WOBURN, Mass., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization and development of ...
The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising questions about whether the agency's new leadership may be rowing back from ...
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