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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
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
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