Johnson & Johnson achieved a pivotal FDA PMA approval for what is being billed as the first computer-assisted sedation system, now available for endoscopy procedures.
Johnson & Johnson won FDA approval for its Sedasys device to administer the sedative propofol.
The FDA has fueled a pharmaceutical arms race in the painkiller market with the agency's decision last month to bar the sale and production of generic OxyContin, which has become one of the most widely abused opioids among Americans.
South Korean regulators have forced Johnson & Johnson to halt production at an over-the-counter drug plant, and Indian watchdogs are doing the same at a consumer healthcare facility in their country.
Medtronic is padding its fleet of U.S.-approved cardiac devices, winning the FDA's blessing to market new Viva and Evera implants.
The company says that the FDA has picked its antiviral combo--with and without ribavirin-- as a new breakthrough therapy worthy of a swift review and perhaps a shortened clinical trial process ahead of a regulatory decision.
Ever since the FDA started to anoint a short list of drug candidates as "breakthrough" therapies deserving of swift regulatory reviews, the industry has been trying to puzzle out one important question: What does it mean?
Medtronic is following through on its long-held plans to slash jobs in its spinal business, cutting 230 positions as revenues falter. Meanwhile, the FDA slapped its most serious recall label over a potentially deadly flaw with the device giant's deep-brain stimulators.
A federal judge wants biotech investor David Blech behind bars. Blech pleaded guilty last year to trading schemes involving stocks in the biotech companies Pluristem Therapeutics ($PSTI) and Intellect Neurosciences ($ILNS), and yesterday he and his attorney asked U.S. District Judge Colleen McMahon in Manhattan for leniency in his sentencing.
Arena Pharmaceuticals has decided to take its drug application and go home. The drugmaker Friday said it was giving up for now on breaking through the European wall of resistance to its weight-loss drug Belviq. The company, which got FDA approval last year, yanked its application with little explanation.