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UPDATE 1-U.S. FDA approves NPS drug, in move validating Shire takeover deal
2015-01-24 06:29:54| Biotech - Topix.net
The U.S. Food and Drug Administration has approved NPS Pharmaceuticals Inc's drug Natpara to treat a rare hormone disorder, validating a bet by Shire Plc , which recently agreed to acquire NPS for $5.2 billion. Natpara is designed to treat hypoparathyroidism, a condition in which the body's parathyroid gland does not secrete enough parathyroid hormone .
FDA approves Novo Nordisk's weight loss injection, Saxenda
2014-12-26 06:37:52| Biotech - Topix.net
Novo Nordisk today announced that the Food and Drug Administration has approved the new drug application for Saxenda , the first once-daily glucagon-like peptide-1 receptor agonist for chronic weight management. Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity or who are overweight in the presence of at least one weight-related comorbid condition.
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FDA approves new melanoma drug from Bristol-Myers
2014-12-22 23:54:34| Biotech - Topix.net
" The Food and Drug Administration granted accelerated approval Monday to a new drug from Bristol-Myers Squibb to treat the deadliest form of skin cancer. The agency approved Opdivo for patients with hard-to-treat melanoma that cannot be removed via surgery or has spread throughout the body.
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FDA Approves Merck's HPV Vaccine, GARDASIL9, to Prevent Cancers and Other Diseases Caused by Nine HPV types Including Types that Cause About 90% of Cervical Cancer Cases
2014-12-11 23:30:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. GARDASIL 9 includes the greatest number of HPV types in any available HPV vaccine KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Deb Wambold, 215-652-2913orInvestors:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
U.S. FDA approves Amgen leukemia drug ahead of schedule
2014-12-04 00:02:10| Biotech - Topix.net
U.S. health regulators on Wednesday approved an Amgen Inc drug that helps the immune system fight a rare type of leukemia, more than five months ahead of the expected decision date. The drug, blinatumomab, which will be sold under the brand name Blincyto, was approved to treat a form of acute lymphoblastic leukemia for which there are currently virtually no treatment options.
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