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 ...
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application for Gazyva® ...
The FDA’s new practice of releasing redacted complete response letters (CRLs) in the name of “radical transparency” is ...
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 ...
WOBURN, Mass., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization and development of ...
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 ...
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