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FDA Approves Acorda’s Inbrija for OFF Episodes of Parkinson’s Disease

The U.S. FDA approved Acorda Therapeutics’ Inbrija, the first inhaled formula of levodopa (L-dopa) for the intermittent treatment of OFF episodes in Parkinson’s disease patients.

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FDA approves Stemline’s rare blood disease treatment

The U.S. Food and Drug Administration approved Stemline Therapeutics Inc.’s Elzonris for the treatment of a rare blood disease in adults and children aged 2 years and older.

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Alexion wins early U.S. approval for rare blood disorder drug

The U.S. Food and Drug Administration approved Alexion Pharmaceuticals Inc.’s rare blood disorder drug Ultomiris, an early backing that also solidifies the company’s dominant market position.

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FDA Gives Merck Thumbs-Up for Two New Indications

Merck received FDA approval for new indications for the PARP inhibitor Lynparza – which is jointly developed and commercialized by AstraZeneca – and the checkpoint inhibitor Keytruda.

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China approves AstraZeneca, FibroGen anemia drug

China became the first country to approve a new anemia drug from AstraZeneca and FibroGen, well before decisions by regulators in the United States or Europe.

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FDA Approves Herceptin Biosimilar Herzuma

Celltrion Inc. and Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration approved Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Herceptin (trastuzumab).

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Roche’s lung cancer combo treatment wins FDA approval

Roche Holding AG’s Tecentriq immunotherapy in combination with Avastin and chemotherapy won U.S. Food and Drug Administration approval as a first-line treatment for a type of lung cancer.

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FDA approves Meridian Bioscience’s test for herpes in newborns

The U.S. Food and Drug Administration approved the first test – a diagnostic from Meridian Bioscience Inc. – to help detect a type of herpes virus in newborns.

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Astellas Breaks into U.S. Blood Cancer Market with Approval of Xospata for AML

The U.S. Food and Drug Administration green-lit a new treatment for acute myeloid leukemia (AML) for patients who have a rare and life-threatening disease mutation, developed by Astellas Pharma Inc.

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FDA approves Catalyst Pharma’s rare disease drug

The U.S. Food and Drug Administration approved Catalyst Pharmaceuticals Inc.’s drug Firdapse to treat a rare autoimmune disease.

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