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…

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…

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…

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. Source: Drug…

Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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,…

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). Source: Drug…

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…