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FDA Expands Approval of Yervoy (ipilimumab) to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma

PRINCETON, N.J.–(BUSINESS WIRE) July 24, 2017 –Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Yervoy (ipilimumab) injection for intravenous use to now… Read More..

July 24th, 2017

GSK Receives FDA Approval for a New Self-Injectable Formulation of Benlysta (belimumab) for Systemic Lupus Erythematosus

London, UK 21 July 2017 — GSK announced today that the US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody‑positive SLE who are… Read More..

July 21st, 2017

Merck Announces U.S. FDA Grants Tentative Approval for Lusduna Nexvue (insulin glargine injection), a Follow-On Biologic Basal Insulin

KENILWORTH, N.J.–(BUSINESS WIRE) July 20, 2017 –Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for Lusduna Nexvue (insulin… Read More..

July 20th, 2017

Churchill Pharmaceuticals Announces NDA Filing Acceptance for Yonsa by the U.S. FDA

KING OF PRUSSIA, Pa., July 20, 2017 /PRNewswire/ — Churchill Pharmaceuticals, LLC (Churchill), a privately held company devoted to expanding treatment options with oral oncology agents, announces that the New Drug Application (NDA) for Yonsa™… Read More..

July 20th, 2017

Camurus and Braeburn Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use Disorder

Lund, Sweden and Princeton, N.J. — July 20, 2017 — Camurus (NASDAQ STO: CAMX) and Braeburn Pharmaceuticals (“Braeburn”) today announced the completion of the rolling submission of the New Drug Application (NDA) to the U.S. Food and Drug… Read More..

July 20th, 2017
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