GenBioPro, maker of the generic version of the abortion pill mifepristone, has sued the FDA, HHS and DOJ as well as the heads of each of those agencies in an…

The FDA’s latest proposed trial design for evaluating the effectiveness of opioids as chronic pain treatments was met with backlash from pain management and anesthesiology experts who contend the protocol…

Genentech has won full approval for its first-in-class combination therapy aimed at providing curative treatment for patients with previously untreated diffuse large B-cell lymphoma (DLBCL), the most common form of…

Before the passage of the Orphan Drug Act (ODA) in 1983, the logistical challenges and financial downsides of developing a drug for a very small population affected by a rare…

The FDA has deemed Fresenius Kabi’s March 8 recall of its Ivenix Infusion System as Class I, the most serious type of recall, as use of the device may cause…

The FDA would like to have the regulatory authority to restrict new opioid approvals to those that are safer than already-approved and marketed opioids, Commissioner Robert Califf told senators at…

In a new interview posted to its website, top officials in the FDA’s Center for Drug Evaluation and Research (CDER) highlight key benefits of the Guidance Snapshot Pilot Program, which…

The FDA has slapped Abbott Point of Care Canada with a warning letter for marketing a product with design and component changes without applying to the agency for clearance or…

Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause…

Prolonged treatment time and maximum amyloid depletion appear key to slowing the cognitive decline of Alzheimer’s disease, researchers reported at the International Conference on Alzheimer’s & Parkinson’s Disease earlier this…