The FDA has hit the gas on efforts to discover new uses for existing drugs, and Hyderabad, India-based GVK Biosciences has licensed a database to the U.S. agency that includes loads of SAR, pharmacokinetic and toxicity information.
Novo Nordisk has begun to regroup after the FDA denied approval of its blockbuster hopeful, Tresiba, seeking cardiovascular outcomes data on the long-acting insulin that will delay the U.S. launch of the drug by several years. Read more >>
The FDA has hit the biotech group with a request for more preclinical data on IDX20963, which is Idenix's lead drug in the closely watched class of uridine nucleotide prodrugs, sometimes called "nucs" for short.
The FDA jumped off the sidelines in the ongoing discussion about threats to networked medical devices, issuing draft guidance to manufacturers and others to take additional precautions against cyberattacks that endanger patients.
As concerns about the hackability of medical devices mount around the world, the FDA is proposing tighter regulations for manufacturers, suggesting that companies include cybersecurity information along with clinical data when seeking approval.
Children with complex conditions often must rely on medical devices to survive, but, because most are designed for adults, life-saving technologies can also expose kids to additional risks, according to a study.
It took multiple tries and a vote tallied on paper to make sure everything was correct, but finally, we have a verdict. After two days of hearings, on Thursday an advisory panel recommended the FDA keep Avandia on the market and ease restrictions on its use.
A warning letter has been issued to Contract Pharmaceutical Services of Australia, which does drug packaging at a plant in the Sydney suburb of New Ryde.
Dr. Thomas Marciniak, medical team leader of FDA's Division of Cardiovascular and Renal Products, made some expensive promises Wednesday morning before a panel of outside experts tasked with advising the FDA on whether to lift current restrictions on GlaxoSmithKline's diabetes drug Avandia.
Any drug manufacturer that fails to take instructions from FDA is inviting trouble, and that is what Novartis got by releasing products from a Sandoz Ebewe plant after the agency said they had been manufactured using unapproved inspection procedures.