Helping Guide the Way for New Medicines Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s […]

On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy for adult patients with newly […]

Helping Guide the Way for New Medicines Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s […]

Product: Drugs Recipient: Recipient Name Steve Welch Recipient Title Owner Skull Smash LLC 3101 Bartold AvenueMaplewood, MO 63143-3600United States [email protected] Issuing Office: Center for Drug Evaluation […]

Reformulating Drug Products That Contain Carbomers Manufactured With Benzene Guidance 12/28/2023 NDA (new drugs), ANDA (generic drugs), DMF (drug master files), Drug Product, CGMP, Compendial Standards, […]

No. DrugName Active Ingredient Approval Date FDA-approved use on approval date* 59. Ultomiris ravulizumab 12/21/2018 To treat paroxysmal nocturnal hemoglobinuria (PNH)Press ReleaseDrug Trials Snapshot 58. Elzonris […]

What is Artificial Intelligence and Machine Learning? Artificial Intelligence (AI) and Machine Learning (ML) can be described as a branch of computer science, statistics, and engineering […]

Helping Guide the Way for New Medicines Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s […]

Helping Guide the Way for New Medicines Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When […]