FDA

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 and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure.  This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled … Continue reading FDA News: FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

FDA OKs 1st drug to treat smallpox, in case of terror attack

U.S. regulators have approved the first treatment for smallpox — a deadly disease that was wiped out four decades ago — in case the virus is used in a terror attack. Smallpox, which is highly contagious, was eradicated worldwide by 1980 after a huge vaccination campaign. But people born since then haven’t been vaccinated, and … Continue reading FDA OKs 1st drug to treat smallpox, in case of terror attack

FDA to more aggressively tackle disruptive drug shortages

The U.S. Food and Drug Administration wants to more aggressively fight medication shortages that recently have led to rationing of some drugs and disrupted hospital operations. The FDA said Thursday that it’s forming a task force to find ways to improve the supply of crucial drugs. It’s a new approach for the drug regulator, which … Continue reading FDA to more aggressively tackle disruptive drug shortages

Court Appoints Faruqi & Faruqi, LLP As Lead Counsel For Class Action Against Intercept Pharmaceuticals, Inc

NEW YORK, NY– Faruqi & Faruqi, LLP, a leading national securities law firm, announces that it has been appointed as Lead Counsel in DeSmet v. Intercept Pharmaceuticals, Inc., et al., No. 1:17-cv-07371-LAK, a class action alleging violations of the federal securities laws against Intercept Pharmaceuticals, Inc. (“Intercept” or the “Company”) and certain of the Company’s … Continue reading Court Appoints Faruqi & Faruqi, LLP As Lead Counsel For Class Action Against Intercept Pharmaceuticals, Inc

Class Action Settlement Announced Involving Syngenta Corn Seeds

RICHMOND, VA, May 17, 2018 /PRNewswire/ — The following is being released by the Claims Administrator of the settlement reached in In re Syngenta MIR162 Corn Litigation, No. 14-md-2591-JWL-JPO (D. Kan.) and other related actions. Syngenta and Plaintiffs announced a $1.51 billion settlement to resolve class actions and individual cases alleging that Syngenta sold its … Continue reading Class Action Settlement Announced Involving Syngenta Corn Seeds

BacterioScan Receives FDA Clearance For Rapid Infection Detection System

Automated diagnostic system cleared for detection of Urinary Tract Infections Reduces lab time-to-results from two days to three hours St. Louis, MO – BacterioScan, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a 510(k) Premarket Notification clearance for its 216Dx Urinary Tract Infection (UTI) detection system.  The BacterioScan 216Dx system … Continue reading BacterioScan Receives FDA Clearance For Rapid Infection Detection System

Congressman claims undisclosed firm wasn’t ‘doing business’

IOWA CITY, Iowa /February 22, 2018 (AP)(STL.News) —A congressman from Iowa said in a sworn statement made public Thursday that a company he failed to disclose wasn’t “doing business” in 2016, despite claims in its own advertising to the contrary. GOP Rep. Rod Blum filed an amended personal financial disclosure listing himself as the majority … Continue reading Congressman claims undisclosed firm wasn’t ‘doing business’

FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults

SILVER SPRING, Md./ Feb. 15, 2018 (STL.NEWS) — The U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of … Continue reading FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults