Drug approvals, label changes, and FDA drug news.
A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations.
This page features news and information for industry and stakeholders about GDUFA, its fee structure, payment methods, and related information.
Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
Learn about the warnings for sexual enhancement and energy products that contain hidden drugs and other hidden ingredients.
Efficacy supplement (new or revised indication). injectable, subcutaneous. Sponsor: Pfizer Inc
This cohort study quantifies incident drug shortages following supply chain events in Canada and examines drug characteristics associated with increased shortage risk.
Built specifically to mimic the native tricuspid anatomy, the implant is intended to address an unmet patient need.
Original new drug approval. tablet, oral. Sponsor: Casper Pharma Llc
Original biologic license approval. injection. Sponsor: Lupin Limited
Original new drug approval. injection, powder,for solution. Sponsor: Wockhardt Bio Ag
Efficacy supplement (new or revised indication). powder, inhalation. Sponsor: Mannkind
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Janssen Biotech
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Astrazeneca Uk Ltd
Original biologic license approval. vial, single-dose. Sponsor: Abbvie Inc
Efficacy supplement (new or revised indication). tablet, oral. Sponsor: Actelion
Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarring) or with compensated cirrhosis.
Original new drug approval. gel. Sponsor: Galderma Laboratories, L.P
Efficacy supplement (new or revised indication). injectable, iv (infusion). Sponsor: Daiichi Sankyo Inc
Original biologic license approval. injection, powder,for solution. Sponsor: Gilead Sciences Inc
Efficacy supplement (new or revised indication). capsule, oral. Sponsor: Abbvie
Efficacy supplement (new or revised indication). tablet, oral. Sponsor: Abbvie
Efficacy supplement (new or revised indication). injectable, intravenous. Sponsor: Incyte Corp
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Genentech Inc
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Genentech Inc