The company was seeking approval of omburtamab to treat a rare form of nerve cancer in pediatric patients. The FDA’s decision follows a unanimous vote in October against the drug to treat neuroblastoma due to insufficient evidence that it improves overall survival.
The drug will be sold under the brand Rezlidhia and indicated for treating acute myeloid leukemia in patients with a susceptible genetic mutation.
The therapy, Rebyota, targets Clostridium difficile, or C. difficile – a superbug responsible for infections that can cause serious and life-threatening diarrhea. In the United States, the infection is associated with 15,000-30,000 deaths annually.
The drug is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.
The first big breakthrough in 30 years of Alzheimer’s research is providing momentum for clinical trials of “cocktail” treatments targeting the two hallmark proteins associated with the mind-robbing disease.
Philips has been recalling 5.5 million such devices since June 2021 after it became aware that a foam part can deteriorate and threaten users’ health.
The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab).
Hemgenix is an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
The company had said this month that Blenrep failed the main goal of a key study designed to show it was better than an existing treatment on the market, stoking fears that regulatory approval could be rescinded by the FDA.
Iovance Biotherapeutics announced the FDA’s Biologics License Application for lifileucel will likely be completed in Q1 of 2023, a short delay after the agency requested additional data.