FDA granted Breakthrough Therapy designation to Hernexeos (zongertinib tablets) for first-line treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations.
FDA has granted Fast Track designation to CER-1236 for Acute Myeloid Leukemia. CER-1236 is a therapy that engineers a cancer patient’s own T-cell therapeutics that deploy phagocytic mechanisms alongside the array of built-in target cell destroying mechanisms used by T-cells.
The FDA’s Oncology Center of Excellence is inviting academic and patient advocate researchers to propose research questions for Project Collaborate, a crowdsourcing initiative running Sept. 2-26.
At the end of July, after just a few months as director of the Center for Biologics Evaluation and Research, Vinay Prasad resigned.
To fight drug shortages that have dogged all of medicine—including oncology—for decades, the Trump administration is returning to a policy it first enacted during the president’s first term.
FDA is shortening its timeline for publicizing Complete Response Letters, pledging to make them available to the public “promptly” after sponsors receive notice.
FDA has approved an expanded indication of the intravenous formulation of Avtozma (tocilizumab-anoh) to include the treatment of cytokine release syndrome in adults and pediatric patients aged two years and older.
The FDA has granted Breakthrough Therapy Designation to rinatabart sesutecan (Rina-S), an investigational folate receptor alpha-directed, TOPO1-inhibitor antibody-drug conjugate, for the treatment of adult patients with recurrent or progressive endometrial cancer who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy.
Gardiner Harris, acclaimed health care and pharma journalist, on his New York Times bestselling book
In his new book, “No More Tears: The Dark Secrets of Johnson & Johnson,” Gardiner Harris, who was previously the public health and pharmaceutical business reporter for The New York Times, talks about the history of the overuse of red blood cell growth factors in oncology.
FDA granted accelerated approval for Modeyso (dordaviprone) for the treatment of adult and pediatric patients (1 year of age and older) with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
