GO
Loading...

FDA

More

  • UPDATE 1-U.S. FDA approves Bristol-Myers, J&J HIV pills Thursday, 29 Jan 2015 | 6:35 PM ET

    Jan 29- The U.S. Food and Drug Administration on Thursday approved two fixed-dose HIV pills that combine protease inhibitors- one made by Bristol-Myers Squibb Co and the other by Johnson& Johnson- both with a boosting agent produced by Gilead Sciences Inc.. Bristol-Myers said its drug, Evotaz, is a once-daily pill containing Reyataz, also known as atazanavir, a...

  • U.S. FDA approves Bristol-Myers' HIV drug Thursday, 29 Jan 2015 | 5:44 PM ET

    Jan 29- The U.S. Food and Drug Administration has approved the sale of Evotaz, a once-daily combination pill to treat HIV made by Bristol-Myers Squibb Co, the company said on Thursday. The new drug combines Reyataz, also known as atazanavir, a Bristol-Myers' protease inhibitor, with cobicistat, a boosting agent produced by Gilead Sciences Inc..

  • The regulator's decision, which comes in over two months ahead of its review date, represents a fourth indication for the drug, sold by Johnson& Johnson and Pharmacyclics Inc. Although WM occurs only in up to 1,500 patients in the United States each year, the approval highlights the strength of the Imbruvica franchise, Roth Capital Partner's Joseph Pantginis...

  • FDA expands use of Imbruvica to treat rare form of cancer Thursday, 29 Jan 2015 | 11:29 AM ET

    Jan 29- The U.S. Food and Drug Administration said it cleared an expanded use of Imbruvica to treat Waldenström's macroglobulinemia, a rare form of cancer that begins in the body's immune system. The approval represents a fourth indication for the drug, sold by Johnson& Johnson and Pharmacyclics Inc, since its initial approval in November 2013.

  • WASHINGTON, Jan 28- U.S. lawmakers proposed a bill on Wednesday that would create a single food safety agency by bringing together the oversight functions of the Food and Drug Administration, U.S. Department of Agriculture and other agencies. Democratic Senator Richard Durbin from Illinois and Representative Rosa DeLauro, a Democrat from Connecticut, told...

  • Abiomed hits all-time high on sales, new device clearance Wednesday, 28 Jan 2015 | 12:49 PM ET

    NEW YORK— Shares of Abiomed surged to an all-time high Wednesday after posting strong third-quarter results and gaining marketing approval for a new heart device. The Food and Drug Administration granted a humanitarian device exemption for Abiomed's Impella RP, meaning it can be put into use without typical delays. Abiomed Inc. also topped Wall Street...

  • WASHINGTON— The Food and Drug Administration said Wednesday it will require makers of heart-zapping defibrillators to submit more data on the emergency devices after years of recalls and manufacturing problems. Additionally, the FDA will inspect manufacturing plants before companies can begin marketing new devices. The FDA says it has received 72,000...

  • Jan 27- Medical device maker Abiomed Inc raised its full-year revenue forecast and said the U.S. Food and Drug Administration had approved its heart pump, sending its stock nearly 32 percent in extended trading. Abiomed's heart pump, Impella RP, helps blood circulation for up to 14 days in patients who develop acute right heart failure following implantation,...

  • Jan 27- Medical device maker Abiomed Inc raised its full-year revenue forecast and said it had received U.S. approval for its heart pump, sending its stock soaring 24 percent after-hours. Abiomed raised its revenue estimate for the year ending March 31 to $223- $226 million from $209- $212 million. The company said the U.S. Food and Drug Administration had approved...

  • Robert Califf, a top cardiologist and researcher, to oversee its drug, medical device and tobacco policy in what experts said is a coup for the FDA. "This is a great catch for the FDA," said Dr. Califf has run countless clinical studies, published more than 1,000 papers, served as an FDA adviser and has twice been interviewed as a potential FDA commissioner.

  • Jan 26- The U.S. Food and Drug Administration said it approved Teva Pharmaceutical Industries Ltd's generic version of AstraZeneca Plc's blockbuster heartburn drug Nexium, the agency's first such approval for the drug. Nexium raked in about $1.9 billion in global sales in the first half of 2014, according to AstraZeneca's latest earnings statement.

  • FDA names cardiologist to senior leadership position Monday, 26 Jan 2015 | 3:37 PM ET

    Robert Califf, a cardiologist and researcher, to oversee its drug, medical device and tobacco policy, in what experts said is a coup for the FDA. He has run countless clinical studies, served on FDA advisory committees, and was rumored in 2009 to be a potential FDA commissioner before the job went to the current commissioner, Dr. "He is a guy who could very easily be FDA...

  • FDA names Duke cardiologist to No. 2 leadership job Monday, 26 Jan 2015 | 2:31 PM ET

    WASHINGTON— The Food and Drug Administration has named a prominent Duke University cardiologist to its No. 2 leadership position, tasked with overseeing drugs, medical devices and tobacco products. Robert Califf currently serves as a vice chancellor at Duke where his work has focused on best practices for clinical trials, particularly those studying heart...

  • Jan 26- The U.S. Food and Drug Administration approved Rockwell Medical Inc's drug for treating iron loss in chronic kidney disease patients on dialysis, sending the company's shares up about 15 percent in premarket trading. Samimy said she expected Triferic to hit peak sales of $200 million- $250 million in the United States. Rockwell estimates the market for...

  • FDA approves 2nd vaccine against meningitis strain Friday, 23 Jan 2015 | 5:07 PM ET

    WASHINGTON— Federal health regulators have approved a second vaccine to prevent a strain of bacteria that can cause deadly cases of meningitis. The Food and Drug Administration said it cleared Novartis' Bexsero vaccine against a subtype of meningococcal bacteria in people ages 10 to 25. The agency cleared a similar vaccine from Pfizer last October.

  • Lori Simons took the bright orange pill at 3 a.m. Eight hours later, doctors sliced into her brain, looking for signs that the drug was working. With special permission from the Food and Drug Administration and multiple drug companies, an Arizona hospital is testing medicines very early in development and never tried on brain tumors before.

  • Jan 22- A panel of experts on Thursday voted to recommend that U.S. health regulators approve Astellas Pharma Inc's drug for the treatment of rare, often fatal invasive fungal infections that can target patients with blood cancers. The Astellas medicine, which would be sold under the proposed brand name Cresemba, was granted Orphan Drug status by the FDA, which is...

  • Lori Simons took the bright orange pill at 3 a.m. Eight hours later, doctors sliced into her brain, looking for signs that the drug was working. With special permission from the Food and Drug Administration and multiple drug companies, an Arizona hospital is testing medicines very early in development and never tried on brain tumors before.

  • Jan 21- The U.S. Food and Drug Administration approved Novartis AG's injectable drug, Cosentyx, to treat adults with a moderate to severe skin disease called plaque psoriasis. Eli Lilly and Co will begin marketing its IL-17 inhibitor ixekizumab in the first half of 2015, while Amgen Inc and AstraZeneca Plc's brodalumab reported positive results from a...

  • FDA approves Novartis's psoriasis drug Wednesday, 21 Jan 2015 | 12:49 PM ET

    Jan 21- The U.S. Food and Drug Administration said it approved Novartis AG's drug to treat adults with moderate to severe plaque psoriasis.