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Government Agencies FDA

  • The Food and Drug Administration says these products, mostly sold on websites and social media, can be harmful, waste money and result in people not getting approved, effective treatments. The pills, creams and teas are untested and not approved by the FDA. The FDA on Tuesday posted the warning letters it sent to 14 manufacturers.

  • 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.

  • The U.S. Food and Drug Administration approved Renflexis, developed by Samsung Bioepis Co. of South Korea. Its U.S. partner, Merck& Co. of Kenilworth, New Jersey, will market Renflexis. The first biosimilar for Remicade, Inflectra from New York- based Pfizer Inc., went on sale in November at a 15 percent discount.

  • The Food and Drug Administration said Friday that it approved Renflexis, developed by Samsung Bioepis Co. of South Korea. It will be marketed by its U.S. partner, Merck& Co. of Kenilworth, New Jersey. Without insurance, Remicade generally costs more than $30,000 annually for adults; dosage varies with the patient's weight.

  • 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...

  • The FDA also said breastfeeding women shouldn't take them because of possible harm to the baby. The FDA urged parents to carefully read labels of nonprescription cough medicines to avoid codeine and to consult a doctor or pharmacist if needed. On Thursday, FDA said that some children are at higher risk of harm from the medicines because they break down codeine...

  • 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...

  • Coca-Cola Co. and Pepsi Co. soda machines stand in a shopping center parking lot in Jasper, Indiana.

    Sales of soda drinks decreased about 1.2 percent in the United States in 2016, falling for the 12th year in a row.

  • 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...

  • The Food and Drug Administration said in a letter to the company that it needed more information about the drug's safety and the best doses, Lilly said Friday in a statement. Lilly said it disagrees with FDA's conclusions but will work with the agency on a plan to eventually get the drug, baracitinib, approved for U.S. patients. Eli Lilly& Co. and Incyte Corp., its...

  • WASHINGTON, April 14- The U.S. Food and Drug Administration on Friday declined to approve a new drug for rheumatoid arthritis made by Eli Lilly and Co and partner Incyte Corp, the companies said on Friday. FDA indicated that additional clinical data was needed to determine the most appropriate doses of the drug, Olumiant, known also as baricitinib, and to further...

  • The FDA, which said the company failed to disclose at least one death associated with one of the devices, said an inspection of the company's facility in Sylmar, California, raised questions about the safety of several implantable defibrillators and its Merlinzhome monitor, which allows doctors to care remotely for patients with cardiac devices.

  • Merlin@home transmitter

    The FDA raised questions about several devices after an inspection of the company's facility.