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UPDATE 2-BioDelivery's opioid treatment wins FDA approval
2015-10-27 05:17:53| Biotech - Topix.net
BioDelivery Sciences International Inc said the U.S. Food and Drug Administration had approved its opioid treatment for chronic pain, sending the drugmaker's shares up 23 percent in premarket trading on Monday. Belbuca is an opioid film patch and aims to treat patients with chronic pain who need round-the-clock treatment and for whom current alternatives do not suffice.
Tags: update
treatment
approval
wins
FDA Declines To Expand Approval Of Pfizer Arthritis Drug
2015-10-15 19:03:30| Biotech - Topix.net
U.S. health regulators declined to approve Pfizer Inc's oral rheumatoid arthritis drug Xeljanz to treat moderate to severe cases of the scaly skin condition plaque psoriasis, the drugmaker said on Wednesday. Pfizer said it received a so-called complete response letter from the Food and Drug Administration.
Tags: expand
drug
approval
arthritis
FDA expands lung cancer approval for Bristol-Myers' drug
2015-10-10 01:17:07| Biotech - Topix.net
The U.S. Food and Drug Administration on Friday expanded its approval of Bristol-Myers Squibb Co's immunotherapy drug Opdivo for patients with an additional form of advanced lung cancer. The agency said Opdivo may now be used in patients with non-squamous non-small cell lung cancer whose disease has progressed during or after platinum-based chemotherapy.
Tags: drug
approval
cancer
lung
FDA Expands Approval Of Merck's Keytruda To Lung Cancer
2015-10-04 19:17:21| Biotech - Topix.net
The U.S. Food and Drug Administration on Friday approved Merck & Co Inc's immunotherapy, Keytruda, for patients with the most common form of lung cancer whose tumors produce a specific biological marker. The FDA approval for Keytruda in advanced non-small cell lung cancer is for patients whose tumors express PD-L1, a protein targeted by the drug, and includes a companion diagnostic, made by a unit of Agilent Technologies Inc, to measure those protein levels.
Tags: approval
cancer
lung
expands
Amgen seeks FDA approval for monthly dosing option for Repatha
2015-09-11 17:48:27| Biotech - Topix.net
Amgen Inc said it had asked the U.S. Food and Drug Administration to approve a monthly single-dosing option for its recently approved cholesterol drug, Repatha. The FDA approved Repatha, one of two approved treatments in a new class of injectable "bad" cholesterol-lowering drugs called PCSK9 inhibitors, on Aug. 27. The drug is approved for patients with hereditary forms of high cholesterol - heterozygous familial hypercholesterolemia and a rarer homozygous form of the condition, in addition to those with cardiovascular disease.
Tags: option
monthly
approval
seeks
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