In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.
Vinay Prasad, a MAHA-aligned hematologist-oncologist with an avid cyber following, was named director of the FDA Center for Biologics Evaluation and Research, where he will be responsible for the agency’s regulation of vaccines and biologics, including cell and gene therapies.
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.
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.”
Government work isn’t what it used to be.
In a speech before a joint session of Congress, President Trump briefly addressed pediatric cancer, pointing to a 13-year old brain tumor survivor, Devarjaye “DJ” Daniel, who was watching from the gallery, making his dream come true by naming him a Secret Service agent.
Urologic oncologist Wayne Brisbane thought his patient might be a good candidate for focal therapy.
FDA’s cancer czar Richard Pazdur had a “silver anniversary” at the agency recently. So, he invited some guests—the commissioners he had reported to under the Democratic and Republican administrations.
More than a month has passed since Hurricane Helene took out Baxter North Cove plant, which manufactured 1.5 million IV fluid bags per day, supplying 60% of the intravenous solutions nationwide.
The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated as a first-line treatment for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.
