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  • July 26- The U.S. Food and Drug Administration has enhanced warnings of side effects of a group of strong antibiotics used to treat a variety of respiratory and urinary tract infections and limited their use to patients with no alternatives. The antibiotics known as fluoroquinolones include Johnson& Johnson's Levaquin, Bayer's Cipro extended-release...

  • July 25- Drug developer Ocular Therapeutix Inc said the U.S. Food and Drug Administration had denied approval for its treatment for post-operative eye pain. The company said the FDA raised concerns related to its manufacturing process after an inspection of its facility. The company said there were no clinical issues identified in the FDA's letter and that it...

  • July 25- Drug developer Ocular Therapeutix Inc said the U.S. Food and Drug Administration had denied approval for its treatment for post-operative eye pain.

  • July 22- Valeant Pharmaceuticals International said on Friday U.S. regulators have raised concerns over a new eye drop manufactured at a Bausch+ Lomb facility in Florida. The U.S. Food and Drug Administration, in a complete response letter regarding the eye drop for a type of glaucoma, raised concerns over Current Good Manufacturing Practice at the unit.

  • MONTREAL— A Quebec City- based research team has received the green light to begin testing a Zika vaccine on humans in collaboration with U.S.-based partners. The researchers based at Universite Laval are the first in Canada to be authorized by Canada's federal health agency and the U.S. Food and Drug Administration to conduct clinical tests.

  • July 19- Zafgen Inc said it was suspending the development of its lead obesity drug, beloranib, more than six months after the U.S. Food and Drug Administration asked the company to halt all tests on the drug following the death of two patients. The FDA has approved drugs made by Vivus Inc, Orexigen Therapeutics Inc and Arena Pharmaceuticals Inc in the past few years,...

  • July 19- Zafgen Inc said it was suspending the development of its lead obesity drug, beloranib, more than six months after the U.S. Food and Drug Administration asked the company to halt all tests on the drug following the death of two patients. The U.S. Food and Drug Administration asked Zafgen to halt all tests on the drug in December after a second patient died from...

  • July 19- Zafgen Inc said it was suspending the development of its obesity drug, beloranib, and reducing its workforce by about 34 percent, sending its shares tumbling 41.9 percent in extended trading on Tuesday. In December, the U.S. Food and Drug Administration asked Zafgen to halt all tests on the drug after a second patient died from an artery blockage in the lung.

  • July 15- Valeant Pharmaceuticals International Inc's experimental drug to treat the skin disorder psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, according to a preliminary review by the U.S. Food and Drug Administration published on Friday. The review comes two days ahead of a meeting of outside experts who...

  • July 15- Valeant Pharmaceuticals International Inc's experimental drug to treat the skin disorder psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said on Friday. The review comes two days ahead of a meeting of outside experts who will advise the FDA on...

  • The death of the patient with a recurrent brain tumor, was revealed as part of a series of slides in a U.S. Securities and Exchange filing late on Thursday. Ziopharm was not immediately available for comment, and the company's stock tumbled about 22 percent to $4.44 in premarket trading on Friday. Earlier this week, the U.S. Food and Drug administration lifted a...

  • July 13- Novartis AG's cheaper version of Amgen Inc's arthritis drug Enbrel is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. Novartis tested the drug, GP2015, in patients with plaque psoriasis but if approved by the FDA, it would be approved for all...

  • July 12- Juno Therapeutics Inc said U.S. health regulators have removed a clinical hold on its cancer drug trial that was put in place last week following the death of three patients, sending its shares up about 28 percent in extended trading. Last week, the U.S. Food and Drug Administration halted the mid-stage trial of the company's genetically engineered...

  • July 12- Pfizer Inc said on Tuesday the U.S. Food and Drug Administration had expanded the use of its best-selling pneumonia vaccine, Prevnar, to adults aged 18 through 49.. Prevnar has been buoying Pfizer's revenue, helping the company beat Wall Street estimates. The Prevnar range of products grossed annual sales of $6.25 billion in 2015, up 40 percent from a year...

  • July 12- Amgen Inc's cheaper version of AbbVie's top-selling arthritis drug Humira is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committee but typically does. The panel's conclusions were consistent with those...

  • July 12- Amgen Inc's cheaper version of AbbVie's top-selling arthritis drug Humira is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 26-0 that the drug, ABP 501, was similar in potency and safety to the original and that there was no meaningful clinical...

  • July 11- The U.S. Food and Drug Administration on Monday approved Shire Plc's lifitegrast eye drops for treating signs and symptoms of dry eye disease, allowing the company to bring to market its most important pipeline medicine. Lifitegrast, which will be marketed as Xiidra in the United States, is expected to launch in the third quarter. It treats an eye disease...

  • Juno Therapeutics

    Juno plunged more than 31 percent, a day after the FDA halted a study on a potential cancer treatment following two patients deaths.

  • July 8- Amgen Inc's version of AbbVie Inc's Humira arthritis drug, the world's top-selling medicine, appears similar in potency and safety to the original product, U.S. Food and Drug Administration staff members said on Friday. In two large Amgen studies, the Thousand Oaks, California- based company said it showed similar effectiveness to Humira.

  • July 8- Amgen Inc's version of AbbVie Inc's Humira arthritis drug, the world's top-selling medicine, appears similar in potency and safety to the original product, U.S. Food and Drug Administration staff members said on Friday. In two large Amgen-sponsored studies, the Thousand Oaks, California- based company said it showed similar effectiveness to Humira.