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Tag: fda approval
Teva Gets FDA Approval For Cancer Drug
2015-12-08 17:23:41| Biotech - Topix.net
Israel's Teva Pharmaceutical Industries said the U.S. Food and Drug Administration approved an injectable and infusion version of its cancer drug bendamustine. The drug, sold under the brand name Bendeka, is approved for treating cancer patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma.
Tags: drug
approval
cancer
fda
FDA declines expanded approval for Bristol-Myers' Opdivo drug
2015-11-28 01:31:21| Biotech - Topix.net
REUTERS: Bristol-Myers Squibb Co said the U.S. Food and Drug Administration declined to approve its immuno-oncology drug, Opdivo, for its expanded use to treat an additional type of advanced skin cancer. Bristol-Myers said it received a so-called complete response letter from the health regulator, which indicated the need for additional data in the BRAF mutated patient population.
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expanded
approval
fda
BIO Applauds FDA Approval of genetically engineered salmon.
2015-11-25 14:31:07| Industrial Newsroom - All News for Today
After regulatory review, U.S. Food and Drug Administration (FDA) approved genetically engineered (GE) AquAdvantage® Salmon for commercial marketing. In response, BIO President and CEO Jim Greenwood commended the FDA "for taking this very important step in the right direction for the advancement of animal biotechnology innovation." AquAdvantage Salmon, developed by BIO member AquaBounty Technologies, is genetically engineered to reach market weight earlier while using 25% less food.
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bio
salmon
engineered
Bright Plastics Receives FDA Approval of Cleanroom Facility
2015-11-09 11:31:08| Industrial Newsroom - All News for Today
Greensboro, NC Bright Plastics, Inc. a custom injection molding company has received the Food and Drug Administrations (FDA) approval for its cleanroom operations. Bright Plastics maintains an ISO 8, Class 100,000 cleanroom in which various products are produced for the medical industry in a carefully...
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facility
bright
receives
FDA Advisory Committee Recommends The Approval Of Lesinurad For Gout Patients
2015-11-03 04:41:07| drugdiscoveryonline Home Page
AstraZeneca recentlyannounced that the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10-4 to recommend the approval of lesinurad 200 mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI)
Tags: committee
approval
patients
advisory
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