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Wirelessly connected infusion pumps, nurse call systems and medication dispensing systems are highly vulnerable to malicious activity, according to new research by security company Armis.
When combined with Merck’s Keytruda (pembrolizumab), Moderna’s personalized messenger RNA (mRNA) vaccine 4157/V940 cut the risk of recurrence or death by 44 percent in patients with resected stage III/IV melanoma, relative to Keytruda alone.
Alvotech has drawn an FDA Complete Response Letter (CRL) for manufacturing facility deficiencies in its BLA for AVT02, a biosimilar candidate for AbbVie’s mega-blockbuster anti-inflammatory therapy Humira (adalimumab). Read More
There are several “green” pathways to help expedite overseas medical device and in vitro diagnostics (IVD) approval in China — including the innovation, priority and emergency use pathways, as well as special zone policies. Read More
A joint FDA advisory committee has cleared the way for Otsuka and Lundbeck’s Rexulti (brexpiprazole) as a new treatment for dementia-related agitation. Read More
The FDA’s Office of Regulatory Affairs (ORA) needs technological advances to create “one source of truth” rather than the siloed data systems that currently hamper its efforts to modernize inspectional work, according to its chief. Read More
New final guidances from the International Medical Device Regulators Forum (IMDRF) explain how to identify and address cybersecurity risks in older devices containing software and offer advice on large-scale manufacturing and validation of personalized devices. Read More
Over the past week, the FDA issued two final and three draft guidances, as well as requests for comments on several advisory committee meetings, user fees, IND applications and the agency’s data and technology strategic plan. In addition, CDRH released details of the center’s Radiation Sterilization Master File Pilot Program. Read More
CDER’s Office of New Drugs (OND) Director Peter Stein is a nationally recognized leader in pharmaceutical research and development. Before joining the FDA in 2016 as OND deputy director he was a vice president at Merck Research Laboratories and formerly a vice president at Janssen. Read More
The White House said Thursday that it will ask the U.S. Supreme Court to step in to defend the FDA’s 22-year-old decision to approve the abortion drug mifepristone after an appeals court denied the Justice Department’s request to allow full access to the drug on Wednesday. Read More
Bristol Myers Squibb (BMS) and Pfizer have together filed separate lawsuits against two generic drugmakers, seeking to prevent the release of generic versions of Eliquis (apixaban), the blockbuster anticoagulant the pharma giants jointly developed. Read More
A new final guidance advises devicemakers to include 11 categories of information in 510(k) submissions for catheter-based devices to treat peripheral vasculature lesions, including detailed device description, components and mode of operation, comparison with the predicate devices and other details. Read More