FDA Newsfeed

… announced that it had received FDA approval for its drug Talicia … over the comparator arms. FDA Approval Is A Major Win … For Patients The FDA approved Talicia for the … term. Conclusion RedHill Biopharma obtaining FDA approval for Talicia to treat …

… now plans to ask the FDA to review the drug. No … FDA-approved treatment for Alport syndrome … also plans to ask the FDA to review its other lead …

… burn for the under-staffed FDA. Smith Collection/Gado… the Food and Drug Administration (FDA) regulates CBD. SEE ALSO: Why … to be confused by the FDA’s role in regulating cannabis … fall outside the scope of FDA approval. This also means harder …

… US Food and Drug Administration (FDA) for SPN-812 for the … that, if approved by the FDA, can become a unique multi … , which if approved by the FDA, has the potential of becoming …

… , on clinical hold.  The FDA has halted the IGNITE DMD … Safety Monitoring Board (DSMB). The FDA then notified Solid Bio that … data and working with the FDA to resolve the clinical … safety fears – in August, the FDA rejected Sarepta Therapeutics’ DMD drug …

… a largely positive review from FDA staffers on Tuesday, dispelling investor … in patients with cardiovascular disease. FDA staffers on Tuesday said their … suspect the comments of the FDA will largely dispel that,” Chief …

… with it, immediately after the FDA issued an advisory that blood … again." He said the FDA didn't contact him … than an approved use. The FDA, according to the magazine, appeared …

… the Food and Drugs Authority (FDA) in accordance with the Public … . The products were seized from FDA’s operational zones including pharmacies … -Tettey, the Regional Director of FDA in an interview with the …

Xconomy Boston —  The FDA has stopped a clinical trial … an earlier clinical hold. The FDA later allowed the study to … clinical hold letter from the FDA. Photo by Flickr user Amit …

… do with lung disease The FDA initially approved Vascepa in 2012 … a focus during Thursday’s FDA advisory committee meeting than previously … Leerink analyst Ami Fadia. “The FDA has clearly taken its stance … stake in Chinese biotech The FDA is expected to make its …

… .S. Food and Drug Administration (FDA) has approved 3DQuorum™ Imaging Technology … only mammogram clinically proven and FDA approved as superior for all …

… month high Tuesday after the FDA posted a briefing document … Analyst: 'No Surprises' FDA's Endocrinologic and Metabolic … to clinicians and patients," FDA staffers said. Cantor Fitzgerald … -IT results, Chen said FDA staffers seem to be believe …

… .S. Food and Drug Administration (FDA) has placed its Ignite DMD … reported the event to the FDA and the study Data Safety … Monitoring Board. The FDA has notified the company that … data and working with the FDA to resolve the clinical hold …

… goal is to file for FDA approval of roxadustat in this …

… clinical hold by the FDA yet again. FDA Seeks Study Suspension On … After the company notified the FDA and the study Data Safety … evidence of complement activation. The FDA subsequently lifted the hold in … Oil Pill, Agile Awaits FDA Verdict Biotech Stock On The …

… linked to vaping. Acting FDA Commissioner Ned Sharpless testified before … undergone scientific review by the FDA and the agency has … Citizen points out that FDA has had authority to regulate … . JUUL Teen Epidemic Recent FDA data indicates teen e-cigarette …

REUTERS: U.S. Food and Drug Administration staffers reviewing Amarin Corp Plc's fish oil-derived drug said on Tuesday the agency's tests were inconclusive on whether the use of mineral oil as placebo in the company's trial could have impacted …

… for a cardiovascular indication. The FDA's Endocrinologic and Metabolic … , Amarin's only FDA-approved drug. The company also … in preparation of a potential FDA approval for the new indication … . The FDA action date for approval is …

… the Food and Drug Administration (FDA). Under an umbrella contract with … five clinics and 16,000 FDA employees in the National Capital … immunization and surveillance programs to FDA office, laboratory, and field locations …

… .S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation … and their families deserve. The FDA’s decision to grant Breakthrough … AMERICA MASSACHUSETTS INDUSTRY KEYWORD: BIOTECHNOLOGY FDA HEALTH PHARMACEUTICAL CLINICAL TRIALS SOURCE …

… US’ Food and Drug Administration (FDA) has accepted a priority review … Bayer’s Nexavar (sorafenib). “The FDA’s acceptance of our application … forward to working with the FDA to bring the potential of …

(Reuters) - Solid Biosciences Inc said on Tuesday the U.S. Food and Drug Administration has put on hold a trial testing its gene therapy for a muscle-wasting disorder. Last month one of the six patients with Duchenne muscular dystrophy dosed with the …

… The Food and Drug Administration (FDA) on Tuesday advised the public … Burger Chocolate Egg “The FDA verified through post-marketing surveillance … of 2009." The FDA also warned the concerned … are registered with the FDA before purchasing them by …