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  • The FDA also asked the company to submit a Risk Evaluation and Mitigation Strategy for the drug, Natpara. The FDA extension follows an 8-5 vote in favor of the drug's approval by an FDA advisory panel in September. The FDA set Jan. 24 as the review date for the drug.

  • Oct 21- Omeros Corp said it suspended enrolment in a mid-stage study testing its experimental Huntington's drug as the company evaluates data from a concurrent trial in rats, sending its shares down 10 percent before the bell. The drug has been well tolerated in all human trials, Omeros said. The U.S. Food and Drug Administration has asked the company to further...

  • Since 1997, FDA has operated under a proposed rule that allows food manufacturers to get new food additives onto the market by notifying FDA that they are generally recognized as safe. In February, the non-profit Center for Food Safety sued FDA, alleging that the agency failed to follow legal rulemaking requirements. "For more than 17 years, FDA has imposed a lax...

  • Oct 20- BioMerieux SA is working with U.S. health regulators to determine if its test to screen for bio threats could be used to detect the Ebola virus, spokeswoman Suzanne Jones said. Since the system was solely developed for environmental surveillance, it is necessary for BioMerieux to show the U.S. Food and Drug Administration evidence that the test could be...

  • FDA panel unanimously backs Novartis' psoriasis drug Monday, 20 Oct 2014 | 2:28 PM ET

    Oct 20- An advisory panel to the U.S. Food and Drug Administration unanimously recommended the use of Novartis AG's anti-inflammation drug in patients with a type of psoriasis, paving the way for its approval. FDA staff reviewers last week had said the drug's benefits outweighed its risk. The FDA is not obligated to accept the panel's recommendations, but...

  • Chimerix gets FDA approval     Friday, 17 Oct 2014 | 11:50 AM ET

    Chimerix says it has FDA approval to test its experimental anti-viral drug on Ebola patients, reports CNBC's Dominic Chu.

  • Oct 16- Pfizer Inc failed to convince the U.S. Food and Drug Administration to remove a black box warning on its controversial quit-smoking drug Chantix, with an advisory panel to the agency voting against the removal on Thursday. The panel agreed to revisit its stance on the warning label once data from Pfizer's post-marketing study of Chantix is available.

  • Oct 16- The benefits of Novartis AG's anti-inflammation drug outweighed the risks in using it to treat a type of psoriasis, staff reviewers at the U.S. Food and Drug Administration said. There were no major safety issues associated with secukinumab, according to the review posted on the FDA website on Thursday- four days before a panel of outside advisers is...

  • Oct 16- The benefits of Novartis AG's anti-inflammation drug outweighed the risks in using it to treat a type of psoriasis, staff reviewers at the U.S. Food and Drug Administration said. While the FDA is not obligated to accept the recommendations of the panel, it typically does so. The FDA staff based its recommendation on the review of the data from this study,...

  • The first, Esbriet, was developed by InterMune Inc, which Switzerland- based Roche Holding AG agreed to buy for $8.3 billion in August, banking largely on the treatment's potential. The agency's decision marks a crucial milestone in the management of the disease, which affects about 100,000 people in the United States. Roche's drug, known generically as...

  • Oct 15- The U.S. Food and Drug Administration approved two drugs to treat idiopathic pulmonary fibrosis, marking its first-ever approvals for the fatal lung disease with no clear etiology and no cure. Roche Holding AG's Esbriet, which is already in use in Europe and Canada, and privately held German drugmaker Boehringer Ingelheim's Ofev both received the...

  • GW Pharma: Focused on epilepsy     Tuesday, 14 Oct 2014 | 5:22 PM ET

    GW Pharma shares are down sharply after a study of its treatment for ulcerative colitis missed its primary endpoint in a mid-stage trial. GW Pharmaceuticals CEO Justin Gover, says the company's main focus is on its product for epilepsy.

  • Oct 14- Pfizer Inc's quit-smoking drug Chantix received its latest setback on Tuesday after U.S. Food and Drug Administration staff recommended that the drugmaker keep a severe warning on the treatment's label. Chantix is one of Pfizer's most controversial drugs and has a number of severe side effects, including suicidal thoughts, erratic behavior and...

  • Obama: US working on Ebola screening     Tuesday, 7 Oct 2014 | 9:15 AM ET

    CNBC's Meg Tirrell looks at the screening protocols the U.S. is considering to stop Ebola from entering the country.

  • Oct 7- Bristol-Myers Squibb said it withdrew its U.S. marketing application for a drug combination to treat hepatitis C. Bristol-Myers said the combination treatment of daclatasvir and asunaprevir was approved in July for use in Japan. The company plans to submit additional data on daclatasvir from an ongoing study to the U.S. Food and Drug Administration.

  • Battling Ebola     Tuesday, 7 Oct 2014 | 8:01 AM ET

    CNBC's Meg Tirrell, and Dr. Moncef Slaoui, GlaxoSmithKline, discuss the latest efforts to develop an Ebola vaccine.

  • CNBC's Meg Tirrell reports the FDA has given permission for drugmaker Chimerix to provide an antiviral drug to Thomas Eric Duncan, as President Obama looks at ways to strengthen passenger screening for Ebola.

  • While Lilly's shares hardly budged on the news, the ADRs of Israel- based XTL Biopharmaceuticals Inc, which is developing its own lupus treatment, nearly tripled to $5.00. About 1.5 million people in the United States are estimated to suffer from lupus, according to the U.S. Centers of Disease Control and Prevention. The U.S. Food and Drug Administration approved...

  • Oct 2- Ariad Pharmaceuticals Inc said its experimental lung cancer drug was granted "breakthrough therapy" status by the U.S. Food and Drug Administration, sending the company's shares up as much as 13 percent. Ariad said the designation was based on early results that showed the drug continued to fight against lung cancer in patients who did not respond to...

  • Sept 29- Salix Pharmaceuticals Ltd said the U.S. Food and Drug Administration approved an expanded use of its constipation treatment. It will compete with Nektar Therapeutics and AstraZeneca Plc's oral drug Movantik, approved by the FDA earlier this month for the same patient population.