FDA on Signing of the COVID-19 Emergency Relief Bill

FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User…

US Food and Drug Administration Approves ZEPOSIA for Multiple Sclerosis

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s ZEPOSIA® (ozanimod), a New Oral Treatment for…

FDA Provides Emergency Use Authorization to PerkinElmer for COVID-19 Testing

WALTHAM, MA (STL.News) PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier…

Abbott Receives FDA Emergency Use of Authorization & Launches Test for Coronavirus

– The test will be used on the company’s m2000 RealTime system that is currently available…

Kettle Cuisine Midco, LLC, Recalls Ready-To-Eat Soup Products due to Misbranding and Undeclared Allergens

WASHINGTON, DC (STL.News) Kettle Cuisine Midco, LLC, a Lynn, Mass. establishment, is recalling approximately 200 pounds…

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 and…

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 Statement on continued efforts to increase availability of naloxone to help reduce opioid overdose deaths

Silver Spring, MD (STL.News) – Addressing opioid overdose continues to be one of the most urgent…

Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products

FDA compliance policy would prioritize enforcement of premarket authorization requirements for non-tobacco-flavored e-cigarettes SILVER SPRING, MD…

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

Silver Spring, MD (STL.News) – Monday, the U.S. Food and Drug Administration announced that an emergency…

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 requests Allergan voluntarily recall certain breast implants, tissue expanders from market

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration today took significant action to…

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…

Federal judge enters consent decree against Arkansas, J and J Grocery, for insanitary conditions

(STL.News) – The U.S. District Court for the Western District of Arkansas ordered J and L…

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…