The US Food and Drug Administration (FDA) published the internal checklists its staff reference when reviewing drug and biologics applications to determine whether the submission is complete, or ...
AbbVie files for the FDA approval of Rinvoq in alopecia areata, backed by phase III data showing strong hair regrowth and ...
Sanofi SNY announced that the FDA has accepted a regulatory filing seeking to expand the use of its type 1 diabetes (T1D) drug, Tzield (teplizumab), in individuals aged one year and older. The agency ...
The FDA in July 2025 made publicly available over 200 complete response letters—an initiative that the investment community ...
WOBURN, Mass., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization and development of ...
Calgary, Alberta--(Newsfile Corp. - September 23, 2025) - Hemostemix Inc. (HEM:CA) (OTCQB: HMTXF) (FSE: 2VF0), the leading autologous (patient's own) stem cell therapy company offering VesCell™ ...
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 ...
BridgeBio Pharma has taken another step toward the potential approval of its muscle weakness drug candidate BBP-418, reporting statistically significant phase 3 efficacy data that analysts have deemed ...
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