Category archives for: FDA News

FDA Approves Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus

FOSTER CITY, Calif.–(BUSINESS WIRE)–Jul. 18, 2017– Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a…

FDA Approves Vosevi (sofosbuvir, velpatasvir and voxilaprevir) for Hepatitis C

July 18, 2017 — The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet…

Grapefruit Juice and Some Drugs Don't Mix

Grapefruit juice can affect how well some medicines work, and it may cause dangerous side effects.

FDA Approves Nerlynx (neratinib) to Reduce the Risk of Breast Cancer Returning

July 17, 2017 — The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant…

FDA Approves Nerlynx (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer

July 17, 2017 — The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant…

Janssen Announces FDA Approval of Tremfya (guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis

Horsham, PA, July 13, 2017 ― Janssen Biotech, Inc. (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are…

FDA Grants Full Approval for Blincyto (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children

THOUSAND OAKS, Calif., July 11, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) to include…

FDA Approves Endari (L-glutamine oral powder) for Sickle Cell Disease

July 7, 2017 — The U.S. Food and Drug Administration today approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder. “Endari is the…

How to Safely Use Nail Care Products

Love manicures and pedicures? The cosmetic products you use, along with lamps that dry (or ‘cure’) gel nail polishes and artificial nails, are regulated by the U.S. Food and Drug Administration. Here’s what to know about these products to avoid injury or bad reactions and stay safe.

Arbor Pharmaceuticals, LLC Announces FDA Approval for Triptodur (triptorelin)

Atlanta, GA and Lausanne, Switzerland – June 30, 2017 – Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, and Debiopharm International SA, part of Debiopharm Group™, a Swiss-based global biopharmaceutical company,…

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