Category archives for: FDA News

FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade

April 21, 2017 — FDA today approved Renflexis (infliximab-abda) for multiple indications. Renflexis is administered by intravenous infusion. This is the second FDA-approved biosimilar to U.S.-licensed Remicade. A biosimilar product is a biological…

Codeine and Tramadol Can Cause Breathing Problems for Children

The FDA is strengthening drug labels for codeine and tramadol to protect children and nursing babies.

FDA Approves Genentech’s Lucentis (ranibizumab) for all Forms of Diabetic Retinopathy

South San Francisco, CA — April 17, 2017 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) 0.3 mg for the monthly…

The FDA Supports Research to Reduce Health Disparities

Scientific researchers now are working on how to reduce health disparities (differences in health outcomes) among racial and ethnic minorities. And they’re doing it with the help of funding from–and by working with–the U.S. Food and Drug Administration. Learn more.

Autism: Beware of Potentially Dangerous Therapies and Products

There is no cure for autism. And many products claiming to ‘cure’ autism carry significant risks. Learn more about autism and how FDA cracks down on false claims.

Neurocrine Announces FDA Approval of Ingrezza (valbenazine) as the First and Only Approved Treatment for Adults with Tardive Dyskinesia (TD)

SAN DIEGO, April 11, 2017 /PRNewswire/ — Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has approved Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia…

FDA Approves Sovaldi (sofosbuvir) for Chronic Hepatitis C Infection in Pediatric Patients 12 Years and Older

FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 7, 2017– Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental indications for Sovaldi (sofosbuvir 400 mg) tablets for the…

Teva Announces FDA Approval of Austedo (deutetrabenazine) for the Treatment of Chorea Associated with Huntington’s Disease

JERUSALEM–(BUSINESS WIRE)–Apr. 3, 2017– Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved Austedo (deutetrabenazine) tablets for the treatment of chorea…

Ibrance (palbociclib) Receives FDA Regular Approval and Expanded Indication for First-Line HR+, HER2- Metastatic Breast Cancer

March 31, 2017 — Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for its first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, Ibrance…

FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to AbbVie's Humira (adalimumab) Prescribing Information

NORTH CHICAGO, Ill., March 30, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the inclusion of moderate to severe fingernail psoriasis data in…

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