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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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FDA Develops Guidelines to Handle Expected Influx of Gene and Cell Therapy Approvals

Noting that the U.S. Food and Drug Administration expects more than 200 investigational new drug applications (INDs) by 2020 per year – many of them cell and gene therapies – the regulatory agency issued an outline of new procedures planned to be implemented during 2019.

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FDA Approves Record-Breaking 59 Novel Drugs in 2018

Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s diarrhea, migraine headaches and more.

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FDA Approves Expanded Use of Adacel Vaccine for Repeat Vaccination

The U.S. Food and Drug Administration approved the expanded use of Adacel to include repeat vaccination to help protect against tetanus, diphtheria and pertussis.

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FDA approves Amneal’s generic dementia patch

The U.S. FDA approved Amneal Pharmaceuticals’ generic version of Novartis’ Exelon Patch (Rivastigmine Transdermal System) for dementia related to Alzheimer’s and Parkinson’s diseases.

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FDA Approves World’s First Device for Treatment of Premature Babies and Newborns with an Opening in Their Hearts

Abbott announced the U.S. Food and Drug Administration approved the Amplatzer Piccolo Occluder, the world’s first medical device that can be implanted in the tiniest babies using a minimally invasive procedure to treat patent ductus arteriosus (PDA).

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Sprycel Approved in Combination with Chemo in Certain Pediatric Patients with PH+ ALL

Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration expanded the indication for Sprycel tablets to include the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.

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Sanofi’s pediatric hexavalent vaccine approved by U.S. FDA

The U.S. Food and Drug Administration approved Sanofi’s new pediatric vaccine immunizing children against six diseases.

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