In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models.
The Association for Clinical Oncology has reached out to the new leaders of federal health agencies to ensure continued progress in cancer care, research, and patient access, the organization said.
The 2025 AACR Enduring Impact Award for Transformative Service to Cancer Science and Medicine will be presented to FDA’s Richard Pazdur during the AACR Annual Meeting 2025, to be held April 25-30 at the McCormick Place Convention Center in Chicago.
FDA approved penpulimab-kcqx with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
BrainChild Bio Inc. announced that its investigational B7-H3 targeting autologous CAR T-cell therapy has been granted Breakthrough Therapy designation by FDA for the treatment of diffuse intrinsic pontine glioma, an incurable pediatric brain tumor.
As he addressed FDA employees, HHS Secretary Robert F. Kennedy Jr. described the Trump era as a “generational opportunity to make the regulatory agency live up to its foundational ideals” and emerge from the morass of what he described as the “deep state.”
FDA on April 11 approved nivolumab (Opdivo) with ipilimumab (Yervoy) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.
FDA announced on April 10 its efforts to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods.
A federal judge ruled that the FDA lacks the statutory authority to regulate laboratory developed tests, finding squarely in favor of plaintiffs in the consolidated lawsuits brought by American Clinical Laboratories Association, Association for Molecular Pathology, and others. ASCP submitted an amicus brief supporting the plaintiffs.
FDA granted full approval for Vitrakvi (larotrectinib), a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
