Nasdaq

Revance Provides Update on DaxibotulinumtoxinA for Injection Pre-Approval Inspection

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the FDA plans to ...
FiercePharma

FDA hits Biocon's insulin copycat with a CRL as plant awaits pre-approval inspection

Biocon’s insulin copycat aspart hit another roadblock as the FDA issued a complete response letter (CRL), saying the Malaysia production facility still must undergo a pre-approval inspection to ...
Business Insider

Transpire Bio Manufacturing Facility Receives the Establishment Inspection Report Following a Pre-Approval Inspection by the U.S. FDA

Transpire Bio, an integrated, clinical-stage biopharmaceutical company focused on developing inhaled therapeutics for pulmonary and systemic diseases, today announced that the U.S. FDA has completed a ...
JD Supra

FDA Inspection and Audits: What to Expect and How to Prepare

The Food and Drug Administration (FDA) is the federal agency charged with ensuring the safety of foods, medications and other consumer products sold in the United States. In carrying out its duties, ...
BioSpace

AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...