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FDA approves Gilead Sciences' HIV drug cocktail
2015-11-05 21:26:44| Biotech - Topix.net
REUTERS: Gilead Sciences Inc said on Thursday the U.S. Food and Drug Administration approved its HIV drug cocktail, Genvoya, to treat infection in adults and patients 12 years of age and older. Genvoya, a combination tablet approved as a complete regimen, aims to treat patients who have never been treated with HIV therapy.
Tags: drug
sciences
hiv
cocktail
FDA approves GSK's drug Nucala for severe asthma
2015-11-05 01:47:14| Biotech - Topix.net
GlaxoSmithKline Plc won U.S. regulatory approval for its drug Nucala to treat severe asthma, the Food and Drug Administration said on Wednesday. The drug, Nucala, known also as mepolizumab, was approved for use in combination with other therapies for patients 12 and older who have a history of severe asthma attacks.
FDA approves drug that uses herpes virus to fight cancer
2015-10-28 17:54:23| Biotech - Topix.net
The Food and Drug Administration approved the injectable drug from Amgen Inc. for patients with hard-to-treat melanoma, the deadliest form of skin cancer that is expected to be diagnosed in 74,000 U.S. patients this year. For now, the drug is only approved for melanoma tumors that cannot be removed surgically.
FDA Approves KEYTRUDA (pembrolizumab) for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1 with Disease Progression On or After Platinum-Containing Chemotherapy
2015-10-02 20:49:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Patients with EGFR or ALK Genomic Tumor Aberrations Should Have Disease Progression on FDA-Approved Therapy for These Aberrations Prior to Receiving KEYTRUDA KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab) monotherapy, the companys anti-PD-1 (programmed death receptor-1) therapy, at a dose of 2 mg/kg every three weeks, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. Language: English Contact: MerckMedia Contacts:Pamela Eisele, 267-305-3558Courtney Ronaldo, 908-236-1108orInvestor Contacts:Teri Loxam, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: or
express
cell
treatment
FDA Approves Pediatric Indication for EMEND (aprepitant) Capsules in Combination with Other Antiemetic Agents
2015-09-02 14:00:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for EMEND (aprepitant) capsules, a substance P/neurokinin 1 (NK1) receptor antagonist. Language: English Contact: MerckMedia:Doris Li, 908-740-1903An Phan, 908-255-6325orInvestors:Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: combination
agents
indication
pediatric
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