GO
Loading...

Enter multiple symbols separated by commas

Government Agencies FDA

More

  • July 23- Sunesis Pharmaceuticals Inc said the U.S. Food and Drug Administration called for more clinical evidence before considering approval for its cancer drug, sending the company's shares down 60 percent in after-market trading. Sunesis said it would work to complete its filing as fast as possible in Europe and refine its plan to gain approval in the...

  • July 23- Sunesis Pharmaceuticals Inc said the U.S. Food and Drug Administration did not support the filing of a regulatory application for its experimental cancer drug, sending the company's shares down 60 percent in after-market trading. The FDA asked the company for more clinical evidence to support its marketing application, Sunesis said.

  • Novo Nordisk says Flexpro PenMate gets FDA approval Thursday, 16 Jul 2015 | 12:18 PM ET

    COPENHAGEN, July 16- The PenMate injection device for use with Novo Nordisk's Norditropin Flexpro treatment for growth hormone-related disorders has been approved by the U.S. Food and Drug Administration, Novo Nordisk said on Thursday. The device is designed to hide the needle injecting Norditropin into patients. Norditropin is used for children and...

  • Zogenix delays epilepsy drug trials by three months Tuesday, 14 Jul 2015 | 9:50 AM ET

    July 14- Drug developer Zogenix Inc said it would delay by three months the start of late-stage trials for its drug to treat a rare form of epilepsy in children. Zogenix decided to delay the trials for ZX008 after the U.S. Food and Drug Administration asked for more patients to be enrolled in the studies. Zogenix plans to enroll 105 patients in each of the two trials,...

  • July 13- The U.S. Food and Drug Administration approved AstraZeneca Plc's drug, Iressa, as a first-line treatment for a common form of lung cancer. The FDA said on Tuesday the approval was based on results from a trial of 106 patients with previously untreated non-small cell lung cancer. The National Cancer Institute estimates more than 158,000 will die from the...

  • July 13- The U.S. Food and Drug Administration has approved AstraZeneca Plc's drug, Iressa, as a first-line treatment for a common form of lung cancer. The drug was previously approved for use in non-small cell lung cancer patients only after they did not respond to chemotherapy. The FDA said on Tuesday the approval was based on results from a trial of 106 patients...

  • Weighing the risks of ibuprofen Friday, 10 Jul 2015 | 1:56 PM ET
    Weighing the risks of ibuprofen

    Discussing safer alternatives to ibuprofen after the FDA warnings, with Dr. Devi Nampiaparampil, NYU School of Medicine. "All of the alternatives have risks," she explains.

  • July 10- The U.S. food and Drug Administration said it was strengthening an existing warning label that non-aspirin, non-steroidal anti-inflammatory drugs increase the chance of a heart attack or stroke. NSAIDs are used to treat pain and fever from medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu, and some of the better-known...

  • FDA extends calorie count deadline for restaurants Friday, 10 Jul 2015 | 9:00 AM ET
    FDA extends calorie count deadline for restaurants

    The FDA gives restaurants more time to put calorie counts on their menus.

  • MUMBAI/ LONDON, July 10- The U.S. Food and Drug Administration and the World Health Organisation have intensified investigations into India's clinical research firms, industry officials said, after recent probes revealed two leading firms had violated standards. The scrutiny is likely to further hurt India's reputation as a global pharmaceutical hub, as it...

  • FDA strengthens warnings on painkillers Friday, 10 Jul 2015 | 7:00 AM ET
    FDA strengthens warnings on painkillers

    FDA Strengthens Heart Safety Warnings on Painkillers.

  • Before you pop that ibuprofen, read new warnings Thursday, 9 Jul 2015 | 7:35 PM ET
    Ibuprofen tablets

    The FDA is strengthening its warnings about painkillers like ibuprofen, saying they do raise the risk of heart attack or stroke.

  • WASHINGTON, July 9- An advisory panel to the U.S. Food and Drug Administration effectively supported approval of Eli Lilly& Co's experimental lung cancer drug necitumumab on Thursday but recommended measures be taken to mitigate the drug's risks. The panel did not officially vote but an informal poll taken by the FDA indicated most members believe the...

  • Novartis news goes straight to the heart Wednesday, 8 Jul 2015 | 6:00 AM ET
    Novartis news goes straight to the heart

    Novartis wins FDA approval for new combination drug Entresto to treat heart failure.

  • July 7- Novartis AG on Tuesday won U.S. approval for its keenly awaited new heart failure drug Entresto earlier than expected, boosting hopes for a medicine tipped by analysts to reap billions of dollars in annual sales. Novartis is looking to Entresto to help revive its fortunes as the blood pressure pill Diovan- a major source of the company's profits in the past-...

  • FDA approves Novartis' heart failure drug Tuesday, 7 Jul 2015 | 4:47 PM ET

    July 7- The U.S. Food and Drug Administration said it approved Novartis AGs' drug to treat heart failure.

  • Seprafilm, developed by Genzyme, is used to reduce abnormal internal scarring following surgery, by separating tissues and organs while they heal. The FDA and Genzyme, which was bought by Sanofi in 2011, were not immediately available for comment. FDA database of Manufacturer and User Facility Device Experience cites at least nine reports that link Seprafilm...

  • July 7- Consumer watchdog Public Citizen said it petitioned the U.S. health regulators to withdraw approval of Sanofi SA's Seprafilm and order a recall, saying the surgical implant has been associated with side effects including death. Seprafilm, developed by Genzyme, is used to reduce abnormal internal scarring following surgery, by separating tissues and...

  • July 2- Vertex Pharmaceuticals Inc's unique combination therapy for a rare lung disorder was given the green light by U.S. health regulators, extending the company's reach to the most common form of genetic mutation responsible for cystic fibrosis. Orkambi, a combination of Vertex's approved drug Kalydeco and a new compound called lumacaftor, is intended for...

  • July 2- Vertex Pharmaceuticals Inc's combination therapy for a rare lung disorder was approved by U.S. health regulators, extending the company's reach to now treat the most common form of genetic mutation responsible for cystic fibrosis. Orkambi, a combination of Vertex's approved drug Kalydeco and a new compound called lumacaftor, is intended for patients...