Cramer has been looking at long-term losers to see if any show potential. He’s found something.» Read More
Markey's proposal differs from legislation approved by a Senate committee on Wednesday that would give the FDA oversight only over compounding pharmacies that make sterile products and ship them across state lines.
WASHINGTON-- The Food and Drug Administration said Thursday it approved a new blood test from Roche to help doctors diagnose diabetes. The FDA said Roche's test is the first to be approved to diagnose the disease.
SEATTLE-- Omeros Corp. said Thursday it will start two midstage clinical trials of its drug OMS824 later this year, giving its stock a boost. Omeros said Thursday that the Food and Drug Administration awarded OMS824 orphan drug status as a treatment for Huntington's.
The advisory panel was convened to help the FDA decide whether to approve the drug, suvorexant, which would be the first in a new class of sedatives designed to help people fall asleep and stay asleep.
WASHINGTON, May 22- Merck& Co's experimental insomnia drug is safe and effective at the lower of two doses studied but not at the higher, a panel of medical experts said on Wednesday.
WESTON, Mass.-- Specialty drugmaker Biogen Idec said Tuesday it submitted a new injectable multiple sclerosis drug to the Food and Drug Administration for U.S. market approval. The company also plans to submit the drug to the European Medicines Agency in coming weeks. Shares of Biogen Idec Inc. rose $6.15, or 2.7 percent, to close Tuesday at $231.33.
May 20- Merck& Co's experimental insomnia drug suvorexant appears generally effective, according to reviewers at the U.S. Food and Drug Administration, but they questioned the company's proposed dosing levels.
Cramer has been looking at long-term losers to see if any show potential. He’s found something.
This marks the first companion diagnostic that detects epidermal growth factor receptor gene mutations to be approved by the U.S. Food and Drug Administration, the agency said.
NEW YORK-- Shares of Invacare Corp. advanced Tuesday after the company said it is making progress in a government review of an Ohio facility.
The FDA in January asked zolpidem manufacturers, including NovaDel Pharma Inc and Swedish drugmaker Meda, to reduce recommended dosages on the drugs' labels. The FDA recommended doses of 5 mg for women and either 5 mg or 10 mg for men for immediate-release zolpidem products such as Sanofi's Ambien.
BOTHELL, Wash.-- Drug developer Seattle Genetics Inc. said Tuesday the Food and Drug Administration has accepted its application to market the lymphatic cancer treatment Adcetris for some additional uses. Seattle Genetics expects the FDA to make a decision by Sept. 14.
Simon Dingemans, Chief Financial Officer at GlaxoSmithKline says that the company's re-engineered approach to R&D is bearing fruit with pipeline looking very healthy.
District Judge Edward Korman in Brooklyn said he would give the FDA until May 13 to ask a federal appeals court in Manhattan to stay the order, which had been scheduled to take effect on Friday.
May 10- The U.S. Food and Drug Administration has approved a new drug to treat chronic obstructive pulmonary disease, a condition often associated with smoking that can include emphysema, chronic bronchitis, or both. The drug, Breo, is an inhaled treatment made by British drugmaker GlaxoSmithKline Plc and Theravance Inc of the United States.
District Judge Edward Korman on April 5 ordered the FDA to lift age restrictions on all levonorgestrel-based emergency contraception- also known as the "morning-after" pill or "Plan B"- to prevent unwanted pregnancies. The FDA has appealed the ruling to the 2nd U.S. Circuit Court of Appeals in Manhattan.
In that time, the number of chemicals in the food supply has risen from fewer than 2,000 to an estimated 10,000, many of which are never reviewed by the FDA because companies and their advisers have declared them to be safe.
Faulty equipment has led to patients being burned or exposed to too much radiation, Jeffrey Shuren, director of the FDA's center for devices and radiological health, said in an interview.
The FDA said the results of a recent study showed that children exposed to valproate products in the womb had lower IQ at the age of six than children who were exposed to other antiepileptics. Abbott Laboratories' Depacon, Depakote, Depakote CP, Depakote ER and Depakene, and Noven Therapeutics LLC's Stavzor and their generics contain valproate.
The FDA issued a warning on its website saying that some third-party publications, health information systems and websites were incorrectly using a truncated version of Kadcyla's generic name.