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 ...
The FDA has granted Compass Pathways with a rolling review for a New Drug Application (NDA) for its investigational ...
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 ...
WASHINGTON, D.C. — The U.S. Food and Drug Administration announced two major actions last week: making its internal drug application checklists public to improve transparency and issuing the ...
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 ...
WASHINGTON — The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday. The ...
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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