Now that AbbVie has followed up on Gilead's game-changing combo with its own directly competitive hep C cocktail, Merck's late-stage player in the field doesn't look quite as revolutionary as it once did. With a new drug application being prepped for a near-term filing, the FDA has decided to drop its breakthrough therapy designation for Merck, possibly slowing the Big Pharma's marketing timeline a bit.
The FDA approved a reformulated version of Zogenix's painkilling Zohydro ER designed to be abuse resistant, marking another step in the battle against opioid abuse and another chapter in a long-running battle over the controversial and potentially addictive medication.
The FDA is asking for $4.9 billion in the next fiscal year, a 9% annual hike that would help fund a broad expansion of the agency as it works to modernize.
Gilead Sciences' hep C drug Sovaldi (sofosbuvir) has had a stellar year, with huge sales because of cure rates that top 90%. But is it safe? According to adverse events reporting, the FDA says it appears to be, but Gilead, like many other drugmakers, has done a poor job of reporting drug side effects.
The FDA and Mylan have issued a reminder of the company's ongoing voluntary recalls for antibiotic and antiseizure drugs manufactured by Mylan's UDL Laboratories.
The FDA has requested $2 million in President Obama's 2016 budget to build precision medicine-related IT infrastructure. The regulator highlighted cloud computing and data security as areas in which it needs to improve.
Bluebird bio nabbed the FDA's breakthrough drug title for LentiGlobin BB305 as a new treatment for beta-thalassemia major, putting one of the industry's top experimental gene therapies back squarely in a promising spotlight.
IBM's artificial intelligence tool Watson is an expert at Jeopardy, but it can't answer the question as to whether the technology should be regulated as a medical device. That decision rests with Congress and the FDA, or perhaps lobbyists.
The FDA issued an administrative order requiring PMA approval for new and existing automated external defibrillators, citing manufacturing issues and pointing to the recall of 2 million of the devices since 2005 as justification for the more stringent regulation.
European regulators have joined the FDA in suggesting joint plant inspections and training with their Indian counterparts. The offers come as India's industry has lost status in recent years as the FDA and other countries have banned Indian plants from shipping to the U.S. and Europe over quality and data-integrity issues.