GO
Loading...

FDA

More

  • 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.

  • Sept 29- Salix Pharmaceuticals Ltd said the U.S. Food and Drug Administration approved an expanded use of its constipation treatment. Salix, which is merging with Cosmo Pharmaceuticals SpA's Irish subsidiary, is in talks with Allergan Inc and Actavis Plc about a potential sale, sources have told Reuters in recent weeks.

  • Sept 29- Tonix Pharmaceuticals Holding Corp said its lead pain drug failed the main goal of a mid-stage study, sending its shares down by nearly half in premarket trading. Tonix said it plans to discuss the trial results and the design for a late-stage trial with the U.S. Food and Drug Administration.

  • Sept 26- Alimera Sciences Inc and pSivida Corp said the U.S. Food and Drug Administration approved their vision-loss treatment Iluvien, following three rejections. Iluvien, which will compete with Regeneron Pharmaceuticals Inc's Eylea and Roche AG's Lucentis, is expected to be available in the United States in early 2015..

  • FDA issues warning letters on Ebola treatment claims Wednesday, 24 Sep 2014 | 3:26 PM ET

    Sept 24- The U.S. Food and Drug Administration issued warning letters to three privately held companies marketing treatments that claim to prevent or treat Ebola. The letters were sent to Newton, New Jersey- based Natural Solutions Foundation, Utah- based dTERRA International LLC and Utah- based Young Living.

  • NEW YORK, Sept 23- Galmed Pharmaceuticals Ltd soared on Tuesday after the company said the Food and Drug Administration had granted fast track designation for its product candidate, aramchol, designed to treat non-alcoholic steato-hepatitis.

  • Sept 22- Canadian drugmaker Tekmira Pharmaceuticals Corp said the U.S. Food and Drug Administration had authorized emergency use of its Ebola treatment to confirmed or suspected patients under an expanded access protocol.

  • The drug, developed by Vivus Inc, is marketed in the United States and Canada by Auxilium Pharmaceuticals Inc. Vivus' stock was up about 13 percent at $4.40 in afternoon trading.

  • The drug was developed by Auxilium Pharmaceuticals Inc and Vivus Inc.. Vivus owns the worldwide development and commercial rights to Stendra for use in sexual dysfunction, with the exception of certain Asian countries in the Pacific Rim.