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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… Read More..

April 21st, 2017

Novartis CAR-T Cell Therapy CTL019 Receives FDA Breakthrough Therapy Designation for Treatment of Adult Patients with r/r DLBCL

Basel, April 18, 2017 – Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult… Read More..

April 18th, 2017

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… Read More..

April 17th, 2017

FDA Grants Genentech’s Tecentriq (atezolizumab) Accelerated Approval as Initial Treatment for Certain People with Advanced Bladder Cancer

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) granted accelerated approval to Tecentriq (atezolizumab) for the… Read More..

April 17th, 2017

FDA Issues Complete Response Letter for Baricitinib

INDIANAPOLIS, April 14, 2017 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application… Read More..

April 14th, 2017
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