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 ...
When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when ...
The Food and Drug Administration (FDA) has issued a Refuse-to-File (RTF) letter to Moderna, Inc. regarding its Biologics License Application (BLA) for the investigational mRNA-based influenza vaccine ...
FDA filing covers renewal applications for VLN® King and VLN® Menthol King, the first combusted cigarettes authorized as Modified Risk Tobacco Products, as 22nd Century advances its regulatory pathway ...
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 ...
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 ...
WEST SACRAMENTO, Calif., March 13, 2025 /PRNewswire/ — Gemini Bioproducts, LLC (“GeminiBio”), a biopharma and advanced therapy raw materials supplier, and a portfolio company of BelHealth Investment ...
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 ...
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