FDA Center for Drug Evaluation and Research - What's New 
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(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
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - 04/10/2024
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access (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
Drug Trials Snapshots: AGAMREE
AGAMREE is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. (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 Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure
The FDA approved a new medication for the reduction of allergic reactions that may occur with accidental exposure to one or more foods. Patients who take this medication must continue to avoid foods they are allergic to. (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 approves tepotinib for metastatic non-small cell lung cancer
On February 15, 2024, the Food and Drug Administration granted traditional approval to tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
