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Government Agencies FDA

  • Finding the truth behind US food system: Kind Snacks CEO

    Daniel Lubetzky, Kind Snacks founder and CEO, talks about a new organization called "Feed the Truth" which aims to bring more transparency to the U.S. food industry.

  • An employee works in a lab at Momenta Pharmaceuticals in Cambridge, Massachusetts.

    Momenta says Pfizer, a key supplier for its multiple sclerosis drug, has received a warning letter from the Food and Drug Administration.

  • Feb 21- Amphastar Pharmaceuticals Inc said on Tuesday that the U.S. Food and Drug Administration had rejected its application to market an intranasal version of the emergency opioid-overdose treatment, naloxone. The Centers for Disease Control and Prevention estimates that 91 Americans die every day from opioid overdoses. Amphastar already sells...

  • Feb 21- Amphastar Pharmaceuticals Inc said on Tuesday that the U.S. Food and Drug Administration had rejected its application to market an intranasal version of the drug naloxone, which is designed to stop or reverse the effects of an opioid overdose. The FDA's complete response letter identifies issues including user human factors study and device...

  • "The idea that perhaps Medicaid programs, which are struggling to pay for those programs, that they could have potentially received rebates is disturbing to me." Mylan has been criticized for listing EpiPen with Medicaid as a generic product even though it listed it with the Food and Drug Administration as a branded product. The classification led to Mylan's...

  • Feb 15- The U.S. Food and Drug Administration on Wednesday approved Valeant Pharmaceuticals International Inc's Siliq to treat adults with moderate-to-severe plaque psoriasis. Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of the disease, and most often begins in people between the ages of 15 and 35..

  • President Donald Trump's vow to roll back government regulations at least 75 percent is causing anxiety for some pharmaceutical executives that a less robust Food and Drug Administration would make it harder to secure insurance coverage for pricey new medicines. The prospect of big change at the regulatory agency comes as drugmakers are under fire for...

  • President Donald Trump's vow to roll back government regulations at least 75 percent is causing anxiety for some pharmaceutical executives that a less robust Food and Drug Administration would make it harder to secure insurance coverage for pricey new medicines. The prospect of big change at the regulatory agency comes as drugmakers are under fire for...

  • Feb 13- Botox maker Allergan Plc said it would buy body-contouring product maker Zeltiq Aesthetics Inc for about $2.48 billion, adding muscle to its line-up of products used to fight fat and smoothen wrinkles. Zeltiq's CoolSculpting System is approved by the U.S. Food and Drug Administration and utilizes a cooling mechanism to reduce the appearance of...

  • A patient with Duchenne muscular dystrophy controls a motorized wheelchair. DMD afflicts about 1 in 3,500 boys worldwide.

    Marathon said the muscular dystrophy drug will cost $89,000 a year, but that the company will provide a "robust" assistance program for uninsured patients.

  • pharmaceuticals pills

    The FDA has become the definitive example of a presidential transition gone awry, Vox reports.

  • Emflaza is the first steroid to win formal FDA approval to treat DMD. Prednisone, another steroid, is frequently prescribed for the disease though it does not have official FDA approval. Patients will no longer be allowed to import the drug now that an FDA- approved product is available.

  • Emflaza is the first steroid to win formal FDA approval to treat DMD. Prednisone, another steroid, is frequently prescribed for the disease though it does not have official FDA approval. Patients will no longer be allowed to import the drug now an FDA- approved product is available.

  • Feb 9- The U.S. Food and Drug Administration on Thursday approved Marathon Pharmaceuticals' Duchenne muscular dystrophy drug, Emflaza, to treat patients aged 5 years and above. DMD is a rare genetic disorder that causes progressive muscle deterioration and weakness and had only one approved treatment in the United States before Emflaza's approval.

  • The FDA, Trump and drug pricing

    David Gortler, associate professor at Georgetown University, says it is good that people are having conversations on the FDA but drug pricing remains complicated.

  • Feb 7- The U.S. Food and Drug Administration has approved Amgen Inc's treatment for secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis, the U.S. biotech company said on Tuesday. The drug, etelcalcetide, will be sold under the brand name Parsabiv, Amgen said, adding that it is the first new therapy approved for the...

  • WASHINGTON, Feb 7- The U.S. Federal Trade Commission filed a complaint against Shire ViroPharma on Tuesday, accusing it of abusing government processes in order to fend off generic competition to its antibiotic Vancocin HCI, the agency said in a statement. The company filed repeated and "unsupported filings" with the U.S. Food and Drug Administration between...

  • A Betamorph E-Cigs employee exhales vapor while smoking an electric cigarette at the company's store in Albuquerque, New Mexico,

    E-cigarettes are now the most commonly used tobacco product among people under 18, NBC News reports.

  • Following approval from the Food and Drug Administration, Phase I clinical trials will start in the first half of this year, the company said on Monday. Its first such "off-the-shelf" cell therapy UCART19, which is being developed with Servier and Pfizer, is now being tested in Phase I trials in Britain for acute lymphoblastic leukaemia and chronic lymphocytic...

  • Feb 2- The U.S. Food and Drug Administration on Thursday expanded the use of Bristol-Myers Squibb Co's Opdivo to include treatment of urothelial carcinoma, the most common type of bladder cancer. Investors were disappointed last month when Bristol-Myers said it would not seek accelerated FDA approval for a combination of Opdivo and another immunotherapy,...