FDA has accepted the Biologics License Application from Replimune Group Inc. for RP1 (vusolimogene oderparepvec) in combination with nivolumab (Opdivo) for patients with advanced melanoma.
The U.S. Food and Drug Administration and the U.S. Department of Health and Human Services Office of Human Research Protections issued Draft Guidance on the inclusion of tissue biopsies in clinical trials.
FDA approved sotorasib (Lumakras) with panitumumab (Vectibix) for adult patients with KRAS G12C-mutated metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
FDA approved acalabrutinib (Calquence) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation.
FDA issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products. If finalized, the United States would be the first country globally to take such a bold, life-saving action to prevent and reduce smoking-related disease and death.
FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition.
FDA granted Rare Pediatric Disease designation for THIO in pediatric-type diffuse high-grade gliomas.
In 1999, Richard Pazdur, a GI oncologist at MD Anderson, saw an FDA recruitment ad in The New England Journal of Medicine. The agency was looking for a director of the FDA Division of Oncology Drug Products.
Colorectal cancer is the second leading cause of cancer-related death in the United States. Accurate and early detection of CRC and precancerous lesions is critical for reducing incidence and preventing deaths from this disease.
FDA issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials.
