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FDA

Latest Headlines

Latest Headlines

FDA is now reporting recalls still awaiting classification

The FDA says it wants to notify the public more quickly about drug recalls. And so it has started a pilot program in which it will send out notifications of recalls that have yet to be classified.

Lilly nabs FDA approval for its blockbuster cancer hopeful ramucirumab

Eli Lilly reached the FDA finish line with its cancer treatment Cyramza (ramucirumab), its star oncology candidate.

Big Pharma sees danger, not safety, in FDA's new social media guidance

The FDA may have released its latest social media guidance in January, but judging by the industry's reaction, it appears some of pharma's marketers don't have any more answers than they did before. In fact, they have more questions.

FDA issued import alert after importer tried to ship saline not approved in U.S.

The FDA says the recent import alert imposed on 0.9% sodium chloride made at a Baxter International plant in Canada was issued because an "importer/consignee" tried to ship some into the U.S. The problem is, the saline made at that plant is not approved for sale in the U.S.

FDA lifts its hold on Juno's cutting-edge cancer drug after deaths trigger delay

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.

Pfizer, PhRMA and others pick holes in FDA social media guidance

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.

UPDATED: Novartis recalls some Ritalin over packaging issue

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.

New report finds Bydureon safest of new class of diabetes drugs

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 scores FDA approval for a new crop of implantable cardiac devices

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.

UPDATED: Impax believes manufacturing issues are fixed

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.