The FDA has lifted a clinical hold placed on a study at Memorial Sloan-Kettering of Juno Therapeutics' cutting-edge approach to treating cancer using genetically tailored T cells, FierceBiotech has learned.
Drugmakers received the first slice of FDA social media guidance in January, and now the FDA's mailbag is filling up with letters on First Amendment protections, "jurisdictional creep" and other topics from the likes of Pfizer and PhRMA.
Attention deficit hyperactivity disorder drugs like Ritalin have been on the FDA shortage list for a variety of reasons. Now add to that packaging problems which have led Novartis to recall nearly 22,000 bottles.
With big money to be made, drugmakers have responded to the global rise in Type 2 diabetes with a host of new classes of treatments that work in different ways. And while that is generally a good thing, the full range of adverse effects of all of these new drugs can't be known until they have been on the market for awhile, and some will fare better than others, a new report states.
Boston Scientific won FDA approval for a new crop of implantable defibrillators and heart failure devices, helping the company move forward with sales and development of its cardiac rhythm management system.
Impax Laboratories had its future sidelined by manufacturing problems that set off a domino effect. Now, it says it is ready to get back in the game.
The FDA sent a warning letter to Canton Laboratories in Vadodara, India, in February for a list of serious infractions, including falsifying data. The agency has taken the next step, issuing an import alert that bans products from the facility.
In the latest black eye for India's pharma industry, Lupin is recalling some 10,000 bottles of its Suprax antibiotic in the U.S. The pills fell short of standards for purity, the FDA said in a statement on its website.
Rapidly expanding Indian generic drugmaker Lupin has stumbled, having to recall 5 lots of the antibacterial med Suprax (cefixime) because it failed purity tests.
A strong regulatory agency and the patient confidence it inspires are essential for both patients and the industry as a whole, Sanofi CEO Chris Viehbacher said Thursday. And while the FDA has made recent strides in restoring the patient trust the agency depends on, Commissioner Margaret Hamburg says it still has some work to do.