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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 analysis. Read More
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 month. Read More
The top citations in FDA warning letters tend not to change radically from one year to the next, but the agency’s warning letters for fiscal 2022 hint at an increased focus on component testing and contractor oversight. Read More
Philips has struck a deal with Amazon Web Services (AWS) to offer its healthcare picture archiving and communication system on AWS’ artificial intelligence (AI)-driven cloud computing platform for an undisclosed financial amount. Read More
Going back to pre-2016 restrictions around the abortion drug Mifeprex — which a federal appeals court now seeks to do — would set off a cascade of problems that could take months, if not longer, to work out and cause the drug to be misbranded in the meantime, according to FDA Principal Deputy Commissioner Janet Woodcock. Read More
The FDA has approved Omisirge (omidubicel-onlv), Gamida Cell’s first-in-class allogeneic umbilical cord-blood stem cell treatment for blood cancers, which carries a unique twist that increases their immune-boosting potential. Read More
Prescription drug advertising is “highly complex” and warrants additional research to assess users’ understanding of the data displays and the “beneficial effect” of the disclosures, says a new study. Read More
Merck announced Monday it will acquire Prometheus Biosciences in a nearly $11 billion deal expected to greatly expand the drugmaker’s portfolio of treatments for autoimmune diseases. Read More
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