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FDA Greenlights Soliris for Rare Autoimmune Disease

The U.S. FDA gave Alexion Pharmaceuticals a thumbs-up for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder in adults that express a specific biomarker.

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FDA Approves Symdeko to Treat Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in CFTR Gene

The U.S. FDA approved Symdeko (tezacaftor/ivacaftor and ivacaftor) for use in children with cystic fibrosis ages 6 through 11 years who have two copies of the F508del-CFTR mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator gene that is responsive to the Vertex Pharmaceuticals Inc. medicine.

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Novo Nordisk Wins Expanded Approval for Victoza

Novo Nordisk’s diabetes drug Victoza (liraglutide) earned approval from the U.S. FDA for an expanded indication for use in children ages 10 to 17 years who have type 2 diabetes.

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FDA approves Emgality as first cluster headache drug

Eli Lilly and Co.’s migraine treatment Emgality became the first drug to gain U.S. approval for decreasing the frequency of episodic cluster headache attacks.

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Vraylar wins U.S. FDA approval for bipolar depression

Allergan Plc’s Vraylar won U.S. regulatory approval to treat depressive episodes of bipolar I disorder, expanding the scope of treatment to a full spectrum of symptoms related to the condition.

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FDA Approves Jakafi for Treatment of Acute GVHD

The U.S. Food and Drug Administration approved Incyte Corp.’s Jakafi as the first treatment for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

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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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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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AbbVie’s Mavyret Approved for Hep C in Pediatric and Adolescent Patients

The U.S. FDA approved AbbVie’s Mavyret for all six strains of hepatitis C in children ages 12 to 17 years. The drug was approved for adults 18 years or older during 2017.

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FDA approves Roche’s small cell lung cancer treatment

Swiss drugmaker Roche Holding AG’s U.S. unit Genentech Inc. won approval for the immunotherapy Tecentriq for a tough-to-treat type of lung cancer.

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