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),…

US Food & Drug Administration News: FDA advances landmark policy changes to modernize mammography services and improve their quality

Proposed rule would require breast density reporting, enhance the FDA’s ability to enforce mammography facilities’ compliance…

US Food & Drug Administration News: FDA approves new oral drug, Mayzent, to treat multiple sclerosis

SILVER SPRING, MD (STL.News) – The U.S. Food and Drug Administration yesterday approved Mayzent (siponimod) tablets…

FDA News: FDA approves device, Optimizer Smart system, for treating moderate to severe chronic heart failure

SILVER SPRING, MD (STL.News) – The U.S. Food and Drug Administration yesterday approved the Optimizer Smart…

St Louis Health Alert – FDA Advises To Stop Using Certain Claire’s Products

Claire’s Initiates Voluntary Recall ST LOUIS, MO (STL.News) – The City of St. Louis Department of…

US Food & Drug Administration News: FDA approves a new generic valsartan

Agency prioritizing review of ARB applications to help mitigate shortage of valsartan SILVER SPRING, MD (STL.News)…

FDA News: USDA, FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock, Poultry

SILVER SPRING, MD (STL.News) – The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service…

FDA News: FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic

SILVER SPRING, MD (STL.News) The U.S. Food and Drug Administration yesterday approved Spravato (esketamine) nasal spray, in…

FDA News: FDA warns CanaRx for selling unapproved, misbranded, unsafe imported drugs to unsuspecting Americans

CanaRx claims its drugs are safe and effective medicines; instead, its violations endanger consumers SILVER SPRING,…

FDA News: FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

Products make unproven claims for treating multiple diseases and conditions SILVER SPRING, MD (STL.News) The U.S.…

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,…

FDA News: FDA permits marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium

SILVER SPRING, MD – Jan. 23, 2019 – The U.S. Food and Drug Administration today permitted…

FDA News: FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

SILVER SPRING, MD – The U.S. Food and Drug Administration today released a warning letter issued…

FDA News: FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

SILVER SPRING, MD – Today, the U.S. Food and Drug Administration cleared a mobile medical application…

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

New drug Vitrakvi targets specific receptor kinase that promotes tumors SILVER SPRING, MD – The U.S.…

FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation

SILVER SPRING, MD – The U.S. Food and Drug Administration, along with the Centers for Disease…

WASHINGTON | FDA says it will overhaul criticized medical device system

WASHINGTON— U.S. health officials said Monday they plan to overhaul the nation’s decades-old system for approving…

Business News: AbbVie Receives US FDA Accelerated Approval for VENCLEXTA® (venetoclax) for Treatment of Newly-Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

– Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very…

FDA News: FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

WASHINGTON – The U.S. Food and Drug Administration today alerted health care providers and patients about…

NAACP News: NAACP statement on FDA plan to ban sale of menthol, e-cigarettes

BALTIMORE, MD – NAACP released the following statement following reports of the Food and Drug Administration’s…

FDA News: FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market

SILVER SPRING, MD – Hazardous foods or potentially contaminated products can expose Americans to foodborne illness…

U.S. Food & Drug Administration News: FDA approves new DNA-based test to determine blood compatibility

SILVER SPRING, MD – The U.S. Food and Drug Administration today approved ID CORE XT, a…

U.S. Food & Drug Administration News: FDA approves first treatment for advanced form of the second most common skin cancer

SILVER SPRING, MD – The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for…

U.S. Food & Drug Administration News: FDA provides update on its ongoing investigation into valsartan products

WASHINGTON – The U.S. Food and Drug Administration is updating the public on the agency’s ongoing…

FDA News: Statement from Commissioner Scott Gottlieb, M.D. to support the development of novel nicotine replacement drug therapies to help smokers stop smoking

SILVER SPRING, MD – As a public health agency, there is no greater impact we can…

NEW YORK | Soy “milk” makers may need to find alternative description

NEW YORK  — Soy and almond drinks that bill themselves as “milk” may need to consider…

FDA News: FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

SILVER SPRINGS, MD – The U.S. Food and Drug Administration (FDA) is alerting health care professionals…