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Mylan and Theravance’s COPD treatment gets FDA approval

Theravance Biopharma Inc. and partner Mylan NV won U.S. regulatory approval for their treatment Yupelri for a chronic lung condition that causes breathing-related problems.

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FDA approves Empliciti for new MM indication

Bristol-Myers Squibb snagged regulatory approval from the U.S. FDA for Empliciti (elotuzumab) for adults with multiple myeloma who have received at least two prior therapies.

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FDA Approves Another Indication for Merck’s Keytruda

Merck’s blockbuster anti-PD-1 therapy Keytruda won FDA approval in combination with chemotherapy as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.

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FDA approves Novartis’ copy of bestseller Humira

The U.S. Food and Drug Administration approved Novartis AG’s copy of Humira, the world’s bestselling prescription medicine developed by U.S.-based AbbVie Inc.

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FDA approves TherapeuticsMD’s menopause drug

The U.S. Food and Drug Administration approved TherapeuticsMD’s oral hormone therapy for menopause symptoms such as hot flashes, sleep disturbances and night sweats.

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FDA approves first new flu drug in almost two decades

Japan’s Shionogi and Swiss drugmaker Roche won U.S. FDA approval for Xofluza, the first new flu drug approved by the regulatory agency in nearly 20 years.

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Sanofi’s eczema product Dupixent wins FDA approval to treat asthma

Sanofi SA’s eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma.

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FDA approves Pfizer’s breast cancer drug Talzenna

The U.S. Food and Drug Administration approved Pfizer Inc.’s Talzenna (talazoparib) for an advanced form of breast cancer.

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Bausch Health’s plaque psoriasis lotion gets tentative FDA approval

Bausch Health, formerly Valeant Pharmaceuticals, received tentative U.S. approval to market the plaque psoriasis lotion Bryhali.

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Akcea Therapeutics genetic disease treatment gets FDA approval

The U.S. Food and Drug Administration approved Akcea Therapeutics’ rare genetic disease drug Tegsedi, which was developed along with Ionis Pharmaceuticals.

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FDA Approves Paratek’s Oral Antibiotic Nuzyra

The U.S. FDA approved Paratek Pharmaceuticals Inc.’s Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia and acute skin and skin structure infections.

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Antares Pharma’s testosterone drug gets FDA approval

The U.S. Food and Drug Administration approved Antares Pharma Inc.’s injectable drug Xyosted to treat low testosterone levels in men nearly a year after being rejected.

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Verastem Gets FDA Approval for Leukemia Drug

Shares of Verastem climbed following U.S. regulatory approval for the leukemia drug Copiktra, an inhibitor of phosphoinositide 3-kinase-delta and PI3K-gamma.

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Sun Pharma’s Xelprost Wins FDA Approval

The U.S. FDA approved the New Drug Application of Xelpros 0.005% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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FDA approves AstraZeneca’s drug for rare form of blood cancer

The U.S. FDA approved AstraZeneca Plc’s treatment for hairy cell leukemia, a slow-growing type of blood cancer.

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FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA), a Rare Form of Juvenile Arthritis

Roche Group member Genentech announced today that the U.S. FDA approved the subcutaneous formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

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Boost for ‘made in China’ medicine as Chi-Med wins key approval

Hutchison China MediTech won Chinese approval for a closely watched new cancer drug in a significant boost for “made in China” medicine.

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Bayer’s hemophilia A treatment gets U.S. FDA approval

The U.S. FDA approved Bayer AG’s long-acting treatment for hemophilia A, a rare genetic disorder in which blood does not clot easily.

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U.S. FDA Approves Imbruvica For Rare Blood Cancer

The Janssen Pharmaceutical Companies of J&J announced the U.S. FDA approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia.

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Novartis wins EU approval for blood cancer therapy Kymriah

Novartis received European approval for Kymriah, the Swiss drugmaker’s gene-modifying therapy for blood cancer.

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