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U.S. FDA issues recall of Ethicon’s surgical staplers

The U.S. Food and Drug Administration issued a recall of surgical staplers made by Johnson & Johnson’s Ethicon unit, warning that the use of the devices could cause serious injury or death.

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FDA approves first anticoagulant for pediatric patients to treat potentially life-threatening blood clots

The U.S. FDA approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism in pediatric patients 1 month of age and older.

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Celgene Receives European Commission Approvals for Revlimid and Imnovid-Based Triplet Combination Regimens for Multiple Myeloma

Celgene Corporation announced that the European Commission approved two new triplet regimens based on the company’s proprietary IMiD treatments, Revlimid (lenalidomide) and Imnovid (pomalidomide).

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Roche: FDA approves drug combo Venclexta plus Gazyva for previously untreated chronic lymphocytic leukemia

The U.S. Food and Drug Administration approved a treatment using Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukemia.

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FDA Approves Bavencio Plus Inlyta Combination for Patients with Advanced Renal Cell Carcinoma

EMD Serono and Pfizer announced that the U.S. FDA approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma.

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FDA advisory panel votes against Daiichi Sankyo’s blood cancer treatment

Independent experts on an advisory panel to the U.S. Food and Drug Administration voted against Daiichi Sankyo Co. Ltd.’s treatment for adults with a type of acute myeloid leukemia.

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FDA Approves Eylea for Diabetic Retinopathy

The U.S. FDA approved Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) Injection for all stages of diabetic retinopathy, which is the leading cause of vision loss in diabetic patients.

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Cellectar Receives FDA Fast Track Designation for CLR 131 in Relapsed or Refractory Multiple Myeloma

Cellectar Biosciences Inc. announced that the U.S. Food and Drug Administration granted Fast Track Designation for CLR 131 in fourth line or later relapse/refractory multiple myeloma.

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FDA Approves Zebra Medical’s AI Chest X-Ray Product

Israel’s Zebra Medical Vision received approval from the U.S. Food and Drug Administration for the company’s artificial intelligence-based chest X-ray triage product.

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Pfizer Acquires Rare-Drug Company Therachon for $810 Million

Pfizer announced plans to buy Therachon, a rare disease biotech company based in Basel, Switzerland.

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