Category archives for: FDA News

FDA Approves Radicava (edaravone) to Treat Amyotrophic Lateral Sclerosis (ALS)

May 5, 2017 — The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. “After learning about the use of edaravone to…

Hepatitis C Treatments Give Patients More Options

Advances in drug treatments approved by the Food and Drug Administration (FDA) are giving the 3.2 million Americans with chronic hepatitis C a chance at a longer, healthier life. That’s welcome news for baby boomers, a generation that makes up three of four adults with the hepatitis C virus.

Think Before You Ink: Are Tattoos Safe?

Are tattoos safe? Not always. More people are getting tattoos, and some have developed infections from contaminated inks, or had bad reactions to the inks themselves.

AstraZeneca’s Imfinzi (durvalumab) Receives FDA Accelerated Approval for Previously Treated Patients with Advanced Bladder Cancer

May 1, 2017 — AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Imfinzi (durvalumab). Imfinzi is indicated for the…

Takeda Announces FDA Accelerated Approval of Alunbrig (brigatinib)

Cambridge, Mass. and Osaka, Japan – April 28, 2017 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that Alunbrig (brigatinib) has received Accelerated Approval from the U.S. Food and Drug Administration (FDA) for the…

FDA Approves Tymlos (abaloparatide) for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture

WALTHAM, Mass., April 28, 2017 (GLOBE NEWSWIRE) — Radius Health, Inc. (Nasdaq:RDUS), a science-driven fully integrated biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and…

FDA Approves Brineura (cerliponase alfa) for CLN2 Disease, a Form of Batten Disease

April 27, 2017 — The U.S. Food and Drug Administration today approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura is the first FDA-approved treatment to slow loss of walking ability (ambulation) in…

FDA Expands Approved Use of Stivarga (regorafenib) to Treat Hepatocellular Carcinoma

April 27, 2017 — The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug…

FDA Approves Xatmep (methotrexate) Oral Solution

Denver, April 26, 2017 — Silvergate Pharmaceuticals, Inc. leaders in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved Xatmep…

HIV and Hepatitis: Know Your Status and Learn About the FDA's Role

The U.S. Food and Drug Administration is working to reduce health disparities among people of different ethnic and racial groups. The agency’s Office of Minority Health is now focusing efforts on educating people about HIV and hepatitis. Here’s what to know about testing, treatment, and the FDA’s role.

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