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).
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.
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.
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).
The U.S. Food and Drug Administration approved a biosimilar to Roche Holding AG’s blockbuster breast cancer treatment Herceptin.
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.
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.
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.
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.
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).
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.
The U.S. Food and Drug Administration approved Sanofi’s new pediatric vaccine immunizing children against six diseases.