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FDA Approves Bausch + Lomb’s Lotemax SM 0.38%

The U.S. FDA approved Bausch + Lomb’s Lotemax SM (loteprednol etabonate ophthalmic gel) 0.38%, a new gel formulation for treating postoperative inflammation and pain following ocular surgery.

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FDA Approves Split-Dosing Regimen for Darzalex

The U.S. Food and Drug Administration gave Janssen Biotech and the Johnson & Johnson company’s research partner Genmab an approval for their Darzalex split-dosing regimen.

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FDA approves Sanofi’s Cablivi for aTTP

The U.S. FDA approved Cablivi in combination with plasma exchange and immunosuppression for treating acquired thrombotic thrombocytopenic purpura (aTTP) in adults.

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FDA approves cheaper Botox rival to treat frown lines

An injection to treat forehead wrinkles is set to rival Allergan plc’s Botox after U.S. regulators approved Evolus Inc.’s cheaper treatment, sending the Newport Beach, Calif.-based company’s shares up about 5 percent.

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FDA Rejects Sunovion’s Parkinson’s Disease Drug

The U.S. Food and Drug Administration rejected Sunovion Pharmaceuticals’ experimental treatment apomorphine sublingual film (APL-130277) for OFF episodes of Parkinson’s disease.

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FDA approves Mylan’s generic Advair

The U.S. Food and Drug Administration approved Mylan NV’s generic version of the GlaxoSmithKline-developed blockbuster asthma treatment Advair, driving shares of Mylan 7 percent higher.

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FDA Approves Imbruvica for 10th Time

FDA approved Imbruvica combined with Gazyva for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma.

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FDA Clears First Diagnostic Test to Detect Emerging Health Threat Mycoplasma genitalium

Hologic Inc. announced that the U.S. Food and Drug Administration granted clearance for the company’s Aptima Mycoplasma genitalium assay, the first FDA-cleared test to detect this under-recognized but increasingly common sexually transmitted infection (STI).

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Abbott Offers a New Option for Physicians Treating Patients with Atrial Fibrillation

Abbott announced U.S. Food and Drug Administration approval of the TactiCath Contact Force Ablation Catheter, Sensor Enabled, a new ablation catheter designed to help physicians accurately and effectively treat atrial fibrillation (AFib).

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Samsung Bioepis biosimilar to Roche’s Herceptin wins FDA nod

The U.S. Food and Drug Administration approved a biosimilar to Roche Holding AG’s blockbuster breast cancer treatment Herceptin.

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