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.
Imfinzi (durvalumab) has been accepted and granted Priority Review by the FDA for the treatment of patients with resectable, early-stage, and locally advanced (stages 2, 3, 4a) gastric and gastroesophageal junction cancers.
In a move that will have direct impact on approval of cancer drugs, George Francis Tidmarsh, an oncologist and a longtime pharmaceutical executive, was named director of the FDA Center for Drug Evaluation and Research.
Laura LoomerVinay PrasadRight-wing activist Laura Loomer is demanding Vinay Prasad’s ouster from FDA, calling him a “saboteur” and “trojan [sic] horse” of the administration’s “Make America Healthy Again” initiative.
A report from the nonpartisan Congressional Budget Office said that proposed cuts at NIH could lead to a decrease in the number of new drugs that come to market in the next three decades.
In April, FDA Commissioner Marty Makary said that the presence of industry employees as members of FDA advisory committees “represents a cozy relationship” between FDA and the businesses it regulates.
FDA’s Oncology Center of Excellence issued an RFA to support U01 cooperative agreements for applied regulatory science research to evaluate cardiotoxicity of oncology therapeutics.
