FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration is alerting health care professionals…

FDA approves new device to improve symptoms in patients with advanced heart failure

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration today approved the Barostim Neo…

FDA approves first of its kind device to treat pediatric patients with progressive idiopathic scoliosis

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration today approved the first spinal…

US Food & Drug Administration approves treatment for patients with rare bone marrow disorder

Silver Spring, MD (STL.News) – Today, the U.S. Food and Drug Administration approved Inrebic (fedratinib) capsules…

FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

FDA also approves drug for second indication in a type of lung cancer Silver Spring, MD…

FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs

Approval marks the second drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs…

FDA warns consumers about the dangerous and potentially life threatening side effects of Miracle Mineral Solution

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration is warning consumers not to…

FDA notifies four companies to remove 44 flavored e-liquid and hookah tobacco products from the market

Agency remains vigilant in investigating and taking action against illegally marketed tobacco products amid epidemic of…

US Food and Drug Administration approves first therapy for rare joint tumor

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

FDA clears new indications for existing Lyme disease tests

Silver Spring, MD (STL.News) – Today, the U.S. Food and Drug Administration cleared for marketing four…

FDA News: FDA approves first treatment for severe hypoglycemia that can be administered without an injection

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration today approved Baqsimi nasal powder,…

FDA suspends facility registration of Texas-based seafood producer, Topway Enterprises, Inc., d.b.a. Kazy’s Gourmet

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration Monday announced it has recently…

FDA approves new treatment for complicated urinary tract, complicated intra-abdominal infections

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration (FDA) has approved Recarbrio (imipenem,…

US Food and Drug Administration approves new treatment for refractory multiple myeloma (RRMM)

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

FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk

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

FDA approves first treatment, Soliris, for neuromyelitis optica spectrum disorder

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

FDA News: FDA approves first treatment for chronic rhinosinusitis with nasal polyps

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration today approved Dupixent (dupilumab) to…

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…