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FDA approves growth hormone deficiency test

Canada’s Aeterna Zentaris Inc. said the U.S. FDA approved its oral test to diagnose adult growth hormone deficiency.

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FDA Approves Genentech’s Perjeta for Adjuvant Treatment of Specific Type of Early Breast Cancer

Genentech announced that the U.S. FDA approved Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.

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Bristol-Myers Squibb Receives FDA Approval for Opdivo as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration approved Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

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Three Hottest Areas of Drug Development to Keep an Eye on in 2018

The last several years has shown a particular focus on immuno-oncology therapies, probably as close to miracle cures as anything seen in recent years. Arpita Dutt, writing for Zacks, predicts what the three hot areas for approvals are likely to be in 2018.

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France fines J&J 25 million euros over painkiller patch

France’s competition authority fined U.S. healthcare group Johnson & Johnson 25 million euros ($29.6 million) after it ruled the company had deliberately slowed market access to generic copies of its painkiller Durogesic.

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Gene therapy developer Orchard Therapeutics raises $110 million

Orchard Therapeutics said it raised $110 million in the second round of funding as the drug developer looks to launch its gene therapy to treat a rare inherited disorder and beef up manufacturing facilities.

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FDA to review Samsung Bioepis’ Herceptin copy

South Korea’s Samsung Bioepis said the U.S. FDA accepted for review its copy of Roche’s blockbuster breast cancer drug Herceptin for potential approval.

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FDA approves NDA for Prexxartan

Carmel Biosciences Inc. received final approval of its New Drug Application from the U.S. Food and Drug Administration for Prexxartan (valsartan) oral solution.

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Pfizer, Exelixis cancer drugs get FDA approval

Cancer treatments from Pfizer Inc. and Exelixis Inc. won expanded approval from the U.S. FDA for use in previously untreated patients.

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Biogen and Ionis Enter into New Collaboration to Identify Novel Therapies for the Treatment of Spinal Muscular Atrophy

Biogen and Ionis Pharmaceuticals announced that they entered into a new collaboration agreement to identify new antisense oligonucleotide drug candidates for the treatment of spinal muscular atrophy (SMA).

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