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Johnson & Johnson wins U.S. FDA approval for bladder cancer drug

Johnson & Johnson’s drug Balversa won U.S. approval as the first targeted therapy for advanced bladder cancer, the Food and Drug Administration announced.

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FDA Approves Expanded Label for Keytruda

The U.S. FDA approved an expanded label for Merck’s anti-PD-1 therapy Keytruda as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

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FDA Approves Evenity For Treating Osteoporosis In Postmenopausal Women At High Risk For Fracture

Amgen and UCB announced that the U.S. FDA approved Evenity (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

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U.S. FDA approves ViiV Healthcare’s Dovato

The FDA approved ViiV’s Dovato as a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for treating HIV-1 infection in adults with no antiretroviral treatment history and no known resistance to either DTG or 3TC.

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FDA Approves ADMA’s Asceniv for Immune Deficiency

The U.S. Food and Drug Administration approved ADMA Biologics’ Asceniv to treat primary humoral immunodeficiency disease (PIDD or PI) in adults and adolescents.

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Fera Pharmaceuticals Announces FDA Approval of Avaclyr

The U.S. Food and Drug Administration approved Fera’s New Drug Application for Avaclyr (acyclovir ophthalmic ointment) 3% for the treatment of herpetic keratitis.

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FDA Green-Lights EMD Serono’s Mavenclad

EMD Serono, a unit of Merck KGaA, announced that the U.S. FDA approved Mavenclad (cladribine) for adults with relapsing-remitting multiple sclerosis and active secondary progressive disease.

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Sage Wins FDA Approval for ‘Game-Changing’ Postpartum Depression Treatment

Sage Therapeutics shares were up after the company won approval for the postpartum depression treatment Zulresso (brexanalone).

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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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FDA approves generic valsartan amid drug shortage

The FDA – looking to ease shortages triggered by several manufacturers recalling the blood pressure medicine valsartan over possible cancer risk – approved a new generic version of the drug.

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