FDA cleared the LTZ Therapeutics’s Investigational New Drug application for LTZ-301, a first-in-class myeloid engager immunotherapy intended to treat relapsed or refractory non-Hodgkin lymphoma.
Cedars-Sinai performed the first robot-assisted microsurgical head-and-neck cancer reconstructive surgery in the United States after the robot device received FDA approval for the procedure.
FDA granted priority review to Boehringer Ingelheim’s new drug application for BI 1810631 (zongertinib) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have HER2 mutations and who have received prior systemic therapy.
Earlier this week, Robert F. Kennedy Jr. was confirmed as secretary of Health and Human Services amid many resignations at federal health agencies and cancellations of NIH and NCAB meetings. All of this happened at a time when the Trump administration is reportedly preparing to fire thousands of HHS workers.
FDA approved Adcetris (brentuximab vedotin) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.
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.
