NPS Pharmaceuticals walked away from an FDA panel meeting with a recommendation to approve its orphan drug, but a lukewarm reception and nagging safety concerns have investors fearing the worst.
Observers tipped the arrival of Apple's long-awaited Watch to bring the worlds of health and tech closer than ever, but this week's announcement was notably light on medical uses. The failure to even mention HealthKit in the presentation has sparked discussion of Silicon Valley's wariness of healthcare regulators in the wake of 23andMe's run-in with the FDA.
The FDA has picked a successor to Howard Sklamberg to oversee the Office of Compliance (OC), Regulatory Focus reports.
For nearly two years, the FDA and a Texas compounder have been sparring over whether its products are safe and whether it will bend to the pressure the agency is exerting. The FDA sent a warning on Tuesday saying that the company cannot affirm its products are safe and that providers were taking a chance by using them.
Startup Tryton Medical has raised $20 million in venture capital to submit its side branch stent to the FDA and market it in Europe. It hopes to have the first coronary stent approved to treat bifurcation lesions in the U.S. Nearly one-third of patients undergoing coronary angioplasty have bifurcation lesions, according to the company.
The FDA has given clearance to startup Otoharmonics for its iPad and iPod Touch application that uses sound therapy to teach the brain to ignore persistent ringing caused by tinnitus.
Merck has secured the FDA's fast-track designation for its latest antibiotic candidate, a mid-stage treatment for complicated infections.
The device industry is awaiting the finalization of the FDA's rule on medical device classification procedures, and will be combing it for the requested changes from the March 2014 proposed rule. More comments asking for an easing of the regulatory burden may be forthcoming, for the FDA extended the public comment period to Sept. 22, according to a notice in the June 12 Federal Register.
Personal mobility startup Whill has raised $11 million in a Series A round following a successful stint on Kickstarter. The financing will go to manufacture and expand distribution of its sleek, off-road device.
Customed received the most serious recall the FDA hands out--a Class I recall. This recall is the largest across-the-board recall the FDA has ever issued to date, 9 times larger than the previous record holding recall.