Drugs@FDA · May 29, 2026
FDA approves Zaynich (zidebactam and cefepime)
Original new drug approval. injection, powder,for solution. Sponsor: Wockhardt Bio Ag
Drugs & FDA · page 6
Drug approvals, label changes, and FDA drug news.
Drugs@FDA · May 29, 2026
FDA expands Afrezza (insulin recombinant human) approval
Efficacy supplement (new or revised indication). powder, inhalation. Sponsor: Mannkind
Drugs@FDA · May 28, 2026
FDA expands Tremfya (guselkumab) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Janssen Biotech
Drugs@FDA · May 28, 2026
FDA expands Imfinzi (durvalumab) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Astrazeneca Uk Ltd
Drugs@FDA · May 27, 2026
FDA approves Decnupaz (pivekimab sunirine-pvzy)
Original biologic license approval. vial, single-dose. Sponsor: Abbvie Inc
Drugs@FDA · May 23, 2026
FDA expands Uptravi (selexipag) approval
Efficacy supplement (new or revised indication). tablet, oral. Sponsor: Actelion
FDA Newsroom · May 22, 2026
FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
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.
Drugs@FDA · May 22, 2026
FDA approves Differin Epiduo Acne Gel (Adapalene And Benzoyl Peroxide) (adapalene, benzoyl peroxide)
Original new drug approval. gel. Sponsor: Galderma Laboratories, L.P
Drugs@FDA · May 22, 2026
FDA expands Datroway (datopotamab deruxtecan-dlnk) approval
Efficacy supplement (new or revised indication). injectable, iv (infusion). Sponsor: Daiichi Sankyo Inc
Drugs@FDA · May 22, 2026
FDA approves Hepcludex (bulevirtide-gmod)
Original biologic license approval. injection, powder,for solution. Sponsor: Gilead Sciences Inc
Drugs@FDA · May 21, 2026
FDA expands Linzess (linaclotide) approval
Efficacy supplement (new or revised indication). capsule, oral. Sponsor: Abbvie
Drugs@FDA · May 20, 2026
FDA expands Venclexta (venetoclax) approval
Efficacy supplement (new or revised indication). tablet, oral. Sponsor: Abbvie
Drugs@FDA · May 18, 2026
FDA expands Zynyz (retifanlimab-dlwr) approval
Efficacy supplement (new or revised indication). injectable, intravenous. Sponsor: Incyte Corp
Drugs@FDA · May 15, 2026
FDA expands Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Genentech Inc
Drugs@FDA · May 15, 2026
FDA expands Tecentriq (atezolizumab) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Genentech Inc
Drugs@FDA · May 15, 2026
FDA approves Immgolis (golimumab-sldi)
Original biologic license approval. injection, solution. Sponsor: Accord Biopharma Inc.
Drugs@FDA · May 15, 2026
FDA approves Baxfendy (baxdrostat)
Original new drug approval. tablet, oral. Sponsor: Astrazeneca Ab
Drugs@FDA · May 15, 2026
FDA expands Enhertu (fam-trastuzumab deruxtecan-nxki) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Daiichi Sankyo
Drugs@FDA · May 15, 2026
FDA expands Enhertu (fam-trastuzumab deruxtecan-nxki) approval
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Daiichi Sankyo
FDA Newsroom · May 12, 2026
FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA
FDA continues to implement its bold food agenda, with two decisive actions focused on food chemical safety.
FDA Newsroom · May 11, 2026
FDA Advances Drug Repurposing to Address Unmet Medical Needs
FDA announced it is soliciting input on efforts with respect to drug repurposing to help address unmet medical needs across a range of diseases and conditions.
FDA Newsroom · May 8, 2026
FDA Grants Seventh Approval under the National Priority Voucher Pilot Program
FDA issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts.
FDA Newsroom · May 6, 2026
FDA Expands AI Capabilities and Completes Data Platform Consolidation
FDA announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.
FDA Newsroom · May 6, 2026
FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight
FDA announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient.