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 ...
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 ...
Corcept Therapeutics’ oral antiglucocorticoid plus chemotherapy slashed risk of ovarian cancer progression by 30% compared to chemotherapy alone. The biopharma intends to take the phase 3 data to ...
CEO Richard Adcock used a presentation at the Citizens Life Sciences Conference to outline the company’s commercial progress ...
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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