Tag: FDA

FDA: S-ICD Generator Recall Due to Short Circuit Risk Is Class I

A company-initiated recall of two models of EMBLEM S-ICD (Boston Scientific) subcutaneous implantable cardioverter defibrillator pulse generators has been categorized as Class I by the US Food and Drug Administration (FDA), the agency announced today. The FDA notes that the advisory, which was communicated to patients and doctors in December, applies to 2825 of the

FDA approves Bristol-Myers' gene therapy for white blood cell cancer

(Reuters) – The U.S. Food and Drug Administration (FDA) on Friday approved Bristol-Myers Squibb’s cell-based gene therapy, Breyanzi, to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or have relapsed after, at least two other types of systemic treatment. The FDA granted approval of Breyanzi for the treatment

FDA authorizes marketing of ACL implant

(HealthDay)—An anterior cruciate ligament (ACL) implant that offers an alternative to traditional ACL reconstruction has received marketing authorization from the U.S. Food and Drug Administration—the first approval for an ACL tear treatment in more than 30 years, the agency announced yesterday. The Bridge-Enhanced ACL Repair (BEAR) Implant received approval under the De Novo premarket review

FDA ‘rapidly working to finalize’ Pfizer coronavirus vaccine approval

Fox News Flash top headlines for December 11 Fox News Flash top headlines are here. Check out what’s clicking on Foxnews.com. The U.S. Food and Drug Administration (FDA) is working toward quickly finalizing and issuing emergency approval for Pfizer and BioNTech’s coronavirus vaccine candidate, according to top FDA officials. “Following yesterday’s positive advisory committee meeting outcome regarding the

FDA warns of dangerous, bogus claims that bleach can treat COVID-19

(HealthDay)—A warning letter has been sent to a company marketing bogus and dangerous chlorine dioxide products for the prevention and treatment of COVID-19, the U.S. Food and Drug Administration says. The fraudulent claims by the Genesis II Church of Health and Healing about its “Miracle Mineral Solution” products are especially concerning in relation to children,

Trump wrongly claims FDA drug is approved to treat coronavirus

Trump claims an anti-malaria drug is APPROVED to treat coronavirus – but is corrected by the FDA head who says it is still ‘experimental’ and will be studied in some American patients President Trump said in a Thursday press conference that the anti-malaria drug hydroxychloroquine had been FDA-approved to treat coronavirus patients  FDA Commissioner Stephen

Swallowable device to detect Barrett’s esophagus receives FDA 510(k) clearance

Investigators at Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center developed the test for early detection of Barrett’s esophagus that offers promise for preventing deaths from esophageal adenocarcinoma. The test involves a novel swallowable balloon device that samples the esophagus and a DNA assay that detects Barrett’s esophagus and esophageal

FDA: ‘Influencers’ promoted vaping without suitable warnings

U.S. regulators moved to discipline vaping companies for inappropriately promoting their flavored nicotine formulas through so-called influencers on Facebook, Twitter and other social media sites. The Food and Drug Administration sent warning letters Friday to four companies that used paid social media influencers to pitch nicotine solutions to their online followers, including flavors like Watermelon

FDA approves first-line therapy for peripheral T-cell lymphoma

(HealthDay)—The U.S. Food and Drug Administration on Friday expanded approval for the use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with specific types of peripheral T-cell lymphoma (PTCL). The FDA stated in a press release that this approval is the first for treatment of newly diagnosed PTCL. Adcetris, a monoclonal

FDA to Ban Most Flavored Electronic Cigarettes

FRIDAY, Nov. 9, 2018 — As part of the U.S. Food and Drug Administration’s efforts to reduce teens’ use of flavored electronic cigarettes, a ban on sales of most flavored e-cigarettes in retail stores and gas stations across the United States is to be introduced, according to media reports. A senior FDA official said details

FDA: Common Diabetes Meds Tied to Serious Genital Infection

THURSDAY, Aug. 30, 2018 — A rare but serious genital infection known as necrotizing fasciitis of the perineum, also called Fournier’s gangrene, has been reported in some patients taking a certain class of type 2 diabetes medicine, according to the U.S. Food and Drug Administration. As a result, the FDA has ordered a new warning

FDA: Some Rx Drugs May Become Available Without Seeing a Doctor

TUESDAY, July 17, 2018 — A new draft guideline from the U.S. Food and Drug Administration suggests Americans could get widely used prescription medicines for cholesterol, high blood pressure, asthma, and migraine headaches without having to see a doctor. The FDA says patients could use a mobile-phone app to help determine if they’re able to

Trials Supporting FDA Approval of Breakthrough Drugs Examined

TUESDAY, July 17, 2018 — Pivotal trials supporting U.S. Food and Drug Administration approvals granted Breakthrough Therapy designation often lack randomization, double-blinding, and control groups, according to a research letter published in the July 17 issue of the Journal of the American Medical Association. Jeremy Puthumana, from the Yale University School of Medicine in New

FDA: Illnesses Tied to Fresh Crab Meat Imported From Venezuela

MONDAY, July 16, 2018 — There have been 12 reported cases of people in the United States becoming sick after eating fresh crab meat from Venezuela, the U.S. Food and Drug Administration says. The agency said the illnesses were caused by Vibrio parahaemolyticus bacteria and advised people to avoid eating fresh crab meat from Venezuela.