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.
Featured Posts
Top 200 Medicines Annual Report 2018: Blockbusters thriving despite tumultuous climate
There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
First Year After Launch Special Feature 2018: Don’t look back, someone might be gaining
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
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.
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.
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.
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.
FDA Approves Imbruvica for 10th Time
FDA approved Imbruvica combined with Gazyva for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma.
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).
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).
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.
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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February 2019 Focus: Agenda 2019, Top 10 Pipelines To Watch, Value Of Pharmaceuticals, and more!