Category archives for: FDA News

FDA Approves Ocrevus (ocrelizumab) for Relapsing and Primary Progressive Forms of Multiple Sclerosis

South San Francisco, CA — March 28, 2017 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Ocrevus (ocrelizumab) as the first and only medicine for both…

FDA Approves Dupixent (dupilumab) for Eczema

March 28, 2017 — The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by…

Tesaro Announces FDA Approval of Zejula (niraparib) for Women with Recurrent Ovarian Cancer

WALTHAM, MA, March 27, 2017 – Tesaro, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Zejula (niraparib), an oral, once-daily poly(ADP-ribose)…

FDA Approves Symproic (naldemedine) for the Treatment of Opioid-Induced Constipation

OSAKA, Japan and FLORHAM PARK, N.J. and STAMFORD, Conn., March 23, 2017 /PRNewswire/ — Shionogi Inc. and Purdue Pharma L.P. announced today that the U.S. Food and Drug Administration (FDA) approved Symproic® (naldemedine) 0.2 mg tablets C-II as a…

FDA Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma

March 23, 2017 — The U.S. Food and Drug Administration today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who…

FDA Approves Xadago (safinamide) as an Add-On Treatment for Patients with Parkinson’s Disease

March 21, 2017 — The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An…

Would Your Child Benefit from a Clinical Trial?

Thinking of enrolling your child in a clinical trial? What can you expect to happen?

FDA Approves Juvéderm Vollure XC for Correction of Facial Wrinkles and Folds in Adults

DUBLIN, March 20, 2017 /PRNewswire/ — Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market Juvéderm Vollure™ XC, for…

Colorectal Cancer: What You Should Know

Colorectal cancer is preventable and, if caught early enough, treatable. Learn who should get screened and when.

FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL)

KENILWORTH, N.J. March 14, 2017 –(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), the company’s anti-PD-1…

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