New indications for approved traditional drugs - 2025 Generic name Brand name Manufacturer Indication(s) Route of administration Month approved* zopapogene imadenovec-drba Papzimeos Precigen...

AAVRh74var adeno-associated virus serotype Rh74var ABSSSI acute bacterial skin and skin structure infections AChR acetylcholine receptor ADHD attention deficit hyperactivity disorder ALK anaplastic...

New indications for approved traditional drugs - 2025 Generic name Brand name Manufacturer Indication(s) Route of administration Month approved* mitomycin intravesical solution Zusduri Urogen...

Jan-Apr 2025 (last posted March 24, 2026): — NADAC Public Report Document #1 — NADAC Public Report Document #2 May-Aug 2025 (last posted January 16, 2026): — NADAC Public Report Document #1 — NADAC...

Generic name Brand name Manufacturer Indication(s) Route of administration Month approved* cosibelimab-ipdl Unloxcyt Checkpoint Metastatic or locally advanced cutaneous squamous cell carcinoma IV...

Generic name Brand name Manufacturer Indication(s) Route of administration Month approved* diazoxide choline Vykat XR Soleno Hyperphagia in Prader-Willi syndrome (≥ 4 years of age) Oral March...

publications Quarterly Drug Approvals: October 2024 This report provides an overview of new drugs and indications approved in 2024 Generic Name Brand Name Manufacturer Indication(s) Month Approved*...

Traditional drug approvals Glossary Traditional drug approvals - 2026 Vaccine and immunization new approvals - 2026 Configure the table properties New indications for approved biosimilars - 2026...

Configure the table properties Cellular and gene therapy and biosimilar approvals Oncology drug approvals - 2026 None Configure the table properties Specialty drug approvals Traditional drug...

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax....