RAPS

FDA publishes NDA filing checklist to avoid application derailments

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 ...
RAPS

When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains

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 Manila Times

22nd Century Group, Inc. Highlights FDA Filing of VLN® MRTP Renewal Applications for Scientific Review

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 ...
JD Supra

FDA Issues Refuse-to-File Letter for mRNA-based Vaccine BLA

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 ...
La Grande Observer

GeminiBio Submits Drug Master File (DMF) to FDA

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 ...
Seeking Alpha

Biofrontera Announces FDA Filing Acceptance of Supplemental New Drug Application for Ameluz® PDT in Superficial Basal Cell Carcinoma

WOBURN, Mass., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization and development of ...