FDA Roundup: February 23, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

WITHDRAWN: FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma
FDA announced its final decision to withdraw approval of melphalan flufenamide (Pepaxto) with dexamethasone to treat certain patients with multiple myeloma. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)
FDA has announced its decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 23, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Biosimilars Guidances
This page lists Biosimilars Guidance documents. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Cefepime and Enmetazobactam Injection
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Trials Snapshots: JESDUVROQ
JESDUVROQ is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor that treats anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Science, Research, and Collaboration Advance Generic Medicines
In 2023, GDUFA-funded research helped expand our understanding of generic drug products, including complex products, and contributed to the development of advanced methods to characterize product quality and performance. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Office of Generic Drugs 2023 Annual Report
Our 2023 Annual Report provides highlights of activities and accomplishments including generic drug approvals, first generic approvals, science and research innovations for generic medicines – including complex generics, and international collaboration. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Remarks by Dr. Califf to the 2024 Biannual Conference of the NYU Grossman School of Medicine Working Group on Compassionate Use and Preapproval Access - 01/30/2024
Speech by Robert M. Califf, M.D. Commissioner of Food and Drugs New York University School of Medicine Biannual conference of the NYU Grossman School of Medicine Working Group on Compassionate Use and Preapproval Access Jan. 30, 2024 New York City, NY (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 21, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: February 20, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 20, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Salvacion USA Inc. - 672252 - 02/13/2024
Unapproved New Drugs/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 20, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Sichuan Deebio Pharmaceutical Co. Ltd. - 669808 - 02/14/2024
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 20, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: February 16, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news