FDA approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner’s National Priority Voucher pilot program, marking the first approval achieved through this review pathway.
FDA granted Tecvayli (teclistamab-cqyv) plus Darzalex Faspro (daratumumab and hyaluronidase-fihj) Breakthrough Therapy designation as second line for patients with relapsed/refractory multiple myeloma.
FDA has cleared the Hugo robotic-assisted surgery system for use in urologic surgical procedures.
FDA approved a new indication for Breyanzi (lisocabtagene maraleucel) as the first CAR T-cell therapy in the U.S. for treatment of adults with marginal zone lymphoma who have failed treatment with or relapsed after two or more prior lines of therapy.
Stepping into the NCI director’s job at the end of a nerve-racking year, Anthony Letai wants you to know that the federal government is not going out of the business of cancer research.
Anthony G. Letai’s initiation as the 18th director of the National Cancer Institute wasn’t exactly smooth.
After three weeks of brutal combat, Richard Pazdur decided that he has had enough.
Pediatric cancer patients are living longer than ever before, according to the AACR Inaugural Pediatric Cancer Progress Report, published on Dec. 4. The five-year survival rate for all pediatric cancers has increased from 63% in the mid-1970s to 87% in 2015-2021.
Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, has instructed his staff to check with him before continuing to work on ongoing submissions to journals or beginning new contract-funded projects to “ensure that we are not engaging in sunk cost fallacy, not publishing obviously erroneous work, and not being distracted from our core mission.”
FDA issued a draft guidance on Dec. 2, outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or reduced.
