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 ...
US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to use the eSTAR filing format at the beginning of 2022. A pilot ...
AbbVie files for the FDA approval of Rinvoq in alopecia areata, backed by phase III data showing strong hair regrowth and ...
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 ...
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 ...
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™ ...
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