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FDA Approves Gilead’s Letairis with Tadalafil for Treatment of PAH

FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 2, 2015– Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Letairis® (ambrisentan) in combination with tadalafil for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to reduce the risks of disease progression and hospitalization for worsening PAH, and to …

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FDA Expands Approval of Merck’s Keytruda for Treatment of Advanced NSCLC

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 company’s anti-PD-1 (programmed death receptor-1) therapy, at a dose of 2 mg/kg every three weeks, for the treatment of patients with …

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FDA Grants Breakthrough Therapy Designation to Bristol-Myers Squibb’s HIV Candidate

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral …

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FDA Approves Sanofi’s PCSK9 Drug Praluent

PARIS and TARRYTOWN, N.Y., July 24, 2015 /PRNewswire/ — Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Praluent® (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated as …

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FDA Approves AstraZeneca’s Iressa for First-Line Use in Patients with Lung Cancer

The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. Lung cancer is the leading cause of cancer-related …

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Takeda Submits New Drug Application for Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma

Cambridge, Mass., July 14, 2015 and Osaka, Japan, July 15, 2015 –Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that a New Drug Application (NDA) has been submitted to the United States (U.S.) Food and Drug Administration (FDA) for ixazomib, an investigational oral proteasome inhibitor for the treatment of patients …

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Novartis’ Promacta Approved for Children with a Rare Blood Disorder

US health regulators expanded approval of Novartis’ Promacta to treat children with a rare blood disorder. Novartis said that the US Food and Drug Administration (FDA) approved Promacta (eltrombopag) for the treatment of children six years and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to …

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FDA Grants Breakthrough Therapy Designation to Actemra for Systemic Sclerosis

US health regulators have granted Breakthrough Therapy designation to Genentech’s Actemra (tocilizumab) for systemic sclerosis. Genentech, a member of the Roche Group, said that the US Food and Drug Administration (FDA) has granted Breakthrough status to Actemra for systemic sclerosis, also known as scleroderma, a rare, chronic disorder characterized by …

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BioMarin Files for Approval of its Duchenne Muscular Dystrophy Drug in Europe

BioMarin Pharmaceutical Inc. has filed for European approval of its investigational drug for a rare, genetic disorder that causes progressive muscle wasting. The company said that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for drisapersen, an investigational antisense oligonucleotide drug candidate for the …

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