Teva (NYSE:TEVA) last week won FDA approval for its humanized monoclonal antibody, Ajovy, designed to prevent migraines. The treatment, which blocks the receptor for a protein that is linked to migraine pain, is available in quarterly and monthly-injection options. Amgen‘s (NSDQ:AMGN) competitive once-monthly product won FDA approval earlier this year. Get the full story at our sister site, […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA clears 1st acute coronary artery perforation stent in 17 years
The FDA said today it approved Biotronik’s PK Papyrus covered coronary stent system intended to treat acute coronary artery perforations, touting it as the first such device to win clearance for that indication in 17 years. Coronary artery perforations can occur during percutaneous coronary intervention procedures and can create life-threatening conditions, the FDA said. In […]
Staar Surgical wins FDA nod for Visian Toric ICL
Staar Surgical (NSDQ:STAA) said yesterday that it won FDA approval for its Visian toric implantable collamer lens designed for correcting myopia with astigmatism. The Monrovia, Calif.-based company said that with the approval, its ICL product line is now cleared for the correction of refractive errors in patients with both myopia and astigmatism. Staar Surgical said that its […]
FDA clears Olympus’ latest biopsy needle
Olympus said it has won FDA clearance for its EZ Shot Plus 25 G needle as well as an expanded indication for the EZ Shot 3 Plus product line for both fine needle aspiration (FNA) and fine needle biopsy (FNB). The approvals “can drive improved staging of disease and the potential to more easily connect patients […]
FDA hopes new disruptive wearables will lead to ‘universal digital future in healthcare’
The FDA is hopeful that devices like the new Apple (NSDQ:AAPL) Watch, which is designed to provide on-the-spot electrocardiogram tests and detect atrial fibrillation, will lead to a “reimagination of healthcare delivery,” according to a recent post from agency head Dr. Scott Gottlieb, but whether having that data will improve overall health has yet to be […]
Genentech wins FDA nod for subcutaneous formulation of arthritis drug
Roche‘s (OTC:RHHBY) Genentech reported this week that the FDA approved the subcutaneous formulation of tocilizumab for the treatment of active systemic juvenile idiopathic arthritis in patients two years and older. The U.S. agency approved the intravenous formulation of Actemra for the same indication in 2011. Get the full story at our sister site, Drug Delivery Business News. […]
Motus GI wins FDA nod for Pure-Vu slim colonoscopy sleeve
Motus GI said today that it won FDA 510(k) clearance for its Pure-Vu slim sleeve as part of its Pure-Vu system, intended for use during slim colonoscopies. With the clearance of the Pure-Vu slim sleeve, Motus GI said that the Pure-Vu system is now cleared for the full range of procedures in the colonoscopy market, with […]
Xact Robotics wins CE Mark for robotic nav & steering system, raises $5m in Series C
Xact Robotics said today it won CE Mark approval in the European Union for its robotics navigation and steering system designed for image-guided percutaneous procedures, and said it raised $5 million in a Series C round of financing. The Caesarea, Israel-based company said its Xact robotics system was cleared for use in planning and accessing targets […]
FDA to review Regeneron’s Eylea for diabetic retinopathy
Regeneron Pharmaceuticals (NSDQ:REGN) said today that the FDA plans to review the supplemental biologics license application for Regeneron’s Eylea aflibercept injection for the treatment of diabetic retinopathy. The U.S. agency plans to make a decision about the blockbuster drug by May 13, 2019. Get the full story at our sister site, Drug Delivery Business News.
FDA pushes back decision date for Acorda’s Parkinson’s drug
Acorda Therapeutics (NSDQ:ACOR) said today that the FDA pushed back its goal date for the agency’s review of Acorda’s inhaled levodopa Parkinson’s therapy. The FDA’s date to make a decision about Acorda’s Inbrija product was moved from Oct. 5, 2018 to Jan. 5, 2019. The Ardsley, N.Y.-based company said the extension is related to submissions it […]
Avinger shareholders accept $5 million settlement
The plaintiffs in a class action suit against Avinger (NSDQ:AVGR) have approved the $5 million settlement that the company offered in March. Shareholders sued the company and several of its officers and directors claiming that they made false and misleading statements about Avinger’s original product, Pantheris, in its 2015 initial public offering. Avinger makes image-guided, catheter-based […]