FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment

Silver Sping, MD (STL.News) – The U.S. Food and Drug Administration issued warning letters to two…

FDA approves Vyleesi for hypoactive sexual desire disorder in premenopausal women

FDA approves Vyleesi (bremelanotide) for hypoactive sexual desire disorder (HSDD) Silver Spring, MD (STL.News) – The…

FDA WARNING: FDA Warns Against the Use of Unauthorized Devices for Diabetes Management

Silver Spring, MD (STL.News) – Today, the U.S. Food and Drug Administration is warning patients and…

FDA approves new treatment for pediatric patients with type 2 diabetes

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration yesterday approved Victoza (liraglutide) injection…

FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

Silver Spring, MD (STL.News) – Yesterday, the U.S. Food and Drug Administration granted accelerated approval to…

FDA News: FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration today approved Emgality (galcanezumab-gnlm) solution…

FDA approves new treatment for hospital-acquired, ventilator-associated bacterial pneumonia

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration yesterday approved a new indication…

FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

SILVER SPRING, MD (STL.News) – The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets…

FDA News: FDA approves new treatments for heart disease caused by a rare disease, transthyretin mediated amyloidosis

Silver Spring, MD (STL.News) – On May 3, the U.S. Food and Drug Administration approved Vyndaqel…

US Food & Drug Administration News: FDA issues warning letter to genomics lab for illegally marketing genetic test

FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict…

Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices

SILVER SPRING, MD (STL.News) – Artificial intelligence and machine learning have the potential to fundamentally transform…

US Food & Drug Administration News: FDA approves treatment for patients with a type of inflammatory arthritis

SILVER SPRING, MD (STL.News) – The U.S. Food and Drug Administration today approved Cimzia (certolizumab pegol)…

US Department of Health and Human Services News: FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism

SILVER SPRING, MD (STL.News) – The U.S. Food and Drug Administration today approved Jatenzo (testosterone undecanoate),…

FDA News: FDA warns patients, doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.

Silver Spring, MD (STL.News) The U.S. Food and Drug Administration today is warning patients and doctors,…