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March 25, 2020

FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups

For Immediate Release: December 13, 2019 Español The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy […]
March 25, 2020

FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations

For Immediate Release: December 10, 2019 Español The U.S. Food and Drug Administration is alerting consumers of a recall of 25 drug, dietary supplement and medical […]
March 25, 2020

FDA approves first generics of Gilenya

For Immediate Release: December 05, 2019 The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment […]
March 25, 2020

FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases

For Immediate Release: December 05, 2019 The U.S. Food and Drug Administration today announced the global launch of CURE ID, an internet-based repository that will allow […]
March 25, 2020

FDA approves novel treatment to target abnormality in sickle cell disease

For Immediate Release: November 25, 2019 Today, the U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease […]
March 25, 2020

Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

For Immediate Release: November 15, 2019 Statement From: Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. Commonly referred […]
March 25, 2020

FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance

For Immediate Release: November 14, 2019 The U.S. Food and Drug Administration today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of […]
March 25, 2020

FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage

For Immediate Release: November 14, 2019 Today, the U.S. Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients […]
March 25, 2020

Statement on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products

For Immediate Release: October 24, 2019 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs – Food and Drug Administration Norman E. “Ned” Sharpless […]
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