FDA approved Gomekli (mirdametinib), a kinase inhibitor from SpringWorks Therapeutics, for adult and pediatric patients two years of age and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection.
When Marsha B. Henderson, former FDA Associate Commissioner of Women’s Health (1998-2019), sat down for an oral history interview upon her retirement from the agency, she could not have foreseen becoming party to a government digital purge 7 years later. Over the past week, the Trump administration has been busy at work deleting government webpages […]
FDA granted orphan drug designation to MB-105, March Biosciences’s first-in-class CD5-targeted CAR T-cell therapy, for the treatment of relapsed/refractory CD5-positive T-cell lymphoma.
The Trump administration did exactly what it said it would do to disorient anyone involved in making policy or touched by it. The president and his crew have “flooded the zone”—the term and the image are theirs, as is the strategy of dropping a flurry of executive orders and memoranda that shake the foundations of the American system of government, raising questions of legality and constitutionality, and, above all, making it a challenge for anyone to see the entire picture and think strategically.
FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by the FDA approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
FDA approved Grafapex (treosulfan), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients one year of age and older with acute myeloid leukemia or myelodysplastic syndrome on Jan. 22.
Janet WoodcockPaul T. KimJanet Woodcock, former director of the Center for Drug Evaluation and Research at FDA, and Paul T. Kim, principal of Kendall Square Policy Strategies LLC, were appointed to the board of directors at Friends of Cancer Research.
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.
