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Government Agencies FDA

  • April 28- The U.S. Food and Drug Administration on Friday approved Novartis AG's Rydapt as an initial treatment for acute myeloid leukemia. AML is a rapidly progressing cancer, which forms in the bone marrow and results in an increased number of white blood cells in the bloodstream. Rydapt has secured approval for adults with newly diagnosed AML that have a...

  • April 27- Biomarin Pharmaceuticals Inc said the annual price for its drug, which won U.S. approval on Thursday, to treat a rare and fatal type of pediatric brain disease is expected to be $486,000 after mandatory government discounts and rebates. The Food and Drug Administration approved Brineura, an enzyme replacement therapy, for patients aged 3 and older to...

  • April 27- The U.S. Food and Drug Administration said on Thursday it had approved Biomarin Pharmaceutical Inc's drug to treat a type of Batten disease, an extremely rare disorder that mainly impacts the nervous system. Biomarin said Brineura is expected to be available in the United States by early June and the company will begin promotion of the drug...

  • April 27- The U.S. Food and Drug Administration said on Thursday it has approved Bayer AG's drug Stivarga to treat liver cancer, the such approval in nearly a decade. About 40,710 people will be diagnosed with liver cancers in 2017 and about 28,920 will die of the diseases, according to the National Cancer Institute. Richard Pazdur, head of the FDA's cancer division,...

  • April 27- The United States Food and Drug Administration said on Thursday it had approved Biomarin Pharmaceutical Inc's drug to treat a type of Batten disease, a rare disorder that mainly affects the nervous system and is ultimately fatal. The drug, Brineura, is an enzyme replacement therapy designed to slow loss of walking ability in patients, three years or...

  • April 27- A U.S. Senate committee voted on Thursday to advance the nomination of Dr. Scott Gottlieb to lead the Food and Drug Administration. The Senate Health, Education, Labor and Pensions Committee voted 14-9 in favor of Gottlieb, a physician, conservative health policy expert and a deputy FDA commissioner during the George W. Bush administration.

  • U.S. SENATE PANEL VOTES IN FAVOR OF ADVANCING NOMINATION OF SCOTT GOTTLIEB AS COMMISSIONER OF FOOD AND DRUG ADMINISTRATION.

  • April 26- Merck& Co's cholesterol-reducing drug Vytorin faces competition for the first time ever after two companies announced progress on their generic versions of a drug that generated more than $1 billion in sales last year. The U.S. Food and Drug Administration on Wednesday approved Impax Laboratories Inc's generic version of Vytorin, while Teva...

  • April 26- The U.S. Food and Drug Administration on Wednesday approved Impax Laboratories Inc's generic version of Merck& Co's cholesterol-reducing drug Vytorin, the first cheap competitor for a drug that in 2016 generated more than $1 billion in sales. Zetia generated 2016 sales of $2.6 billion. Merck faces generic competition this year not only to Vytorin and...

  • Spinraza, a first-of-its-kind medicine for spinal muscular atrophy, was approved by the U.S. Food and Drug Administration in December. The drug, priced at $125,000 per injection in the first year of use, generated sales of $47 million, handily beating the consensus estimate by $30 million. Spinraza is the first major drug launch under Chief Executive Officer...

  • Spinraza, a first-of-its-kind medicine for spinal muscular atrophy, the leading genetic cause of death in infants, was approved by the U.S. Food and Drug Administration in December. The drug, priced at $125,000 per injection in the first year of use, brought in sales of $47 million, handily beating the consensus estimate by $30 million. However, net income...

  • However, the Indianapolis- based drugmaker has suffered setbacks recently, with the U.S. Food and Drug Administration earlier this month declining to approve a new drug for rheumatoid arthritis made by Lilly and partner Incyte Corp. The drugmaker on Tuesday posted a net loss of $110.8 million, or 10 cents per share, in the first quarter, compared with a profit of...

  • The outside of the Food and Drug Administration headquarters is seen in White Oak, Md., on Monday, November 9, 2015.

    South Korea's Samsung Bioepis wins U.S. FDA nod for biosimilar of J&J's Remicade.

  • April 21- Embattled Canadian drugmaker Valeant Pharmaceuticals International Inc, said on Friday that it had priced its recently approved plaque psoriasis treatment at $3,500 per month. The company expects to launch the drug in the United States in the second half of 2017.. The drug secured U.S. Food and Drug Administration approval in February this year.

  • April 20- A U.S. regulatory agency told Texas and Arizona that more than a thousand vials of drugs they ordered for executions in their states from India in 2015, and seized by U.S. The Food and Drug Administration notified the Texas Department of Criminal Justice and the Arizona Department of Corrections that their confiscated shipments of sodium thiopental...

  • BOSTON, April 19- Pfizer Inc has received grand jury subpoenas from the U.S. Justice Department in connection with an antitrust investigation focusing on drugmakers that market intravenous saline solutions. The U.S. Food and Drug Administration in January 2014 added the solutions to its drug shortage list, saying the shortage was triggered by factors...

  • BOSTON, April 19- Pfizer Inc has received grand jury subpoenas from the U.S. Justice Department in connection with an antitrust investigation focusing on drugmakers that market intravenous saline solutions. The U.S. Food and Drug Administration in January 2014 added the solutions to its drug shortage list, at the time saying the shortage was triggered by...

  • BOSTON, April 19- Pfizer Inc has received grand jury subpoenas from the U.S. Justice Department in connection with an antitrust investigation focusing on drugmakers that market intravenous saline solutions. The U.S. Food and Drug Administration in January 2014 added the solutions to its drug shortage list, at the time saying the shortage had been triggered by...

  • April 18- Bioelectronic healthcare company electroCore LLC said on Tuesday that the U.S. Food and Drug Administration had approved its hand-held device to treat cluster headaches. The company anticipates the product will be available in the United States in the third quarter. The device, which can be self-administered, is already approved for use in South...

  • April 17- Genentech, a unit of Swiss drugmaker Roche Holding AG, said on Monday it got approval from the U.S. Food and Drug Administration for its already approved immunotherapy drug, Tecentriq, to treat advanced bladder cancer. Tecentriq, also known as atezolizumab, received the go-ahead under the FDA's accelerated approval program as a first-line treatment...