FDA announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement.
FDA has reassigned the previously announced Prescription Drug User Fee Act goal date of Bristol Myers Squibb’s Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20).
FDA Oncology Center of Excellence has formed the OCE Equity Program.
Sen. Richard J. Durbin (D-IL) has asked Amgen to provide copies of the company’s communications with FDA related to the dosage of Lumakras (sotorasib), a KRAS inhibitor marketed under an accelerated approval for non-small cell lung cancer.
FDA and the European Medicines Agency granted an Orphan Drug Designation to Carthera for the use of carboplatin when used with SonoCloud technology in the treatment with malignant glioma.
If the FDA Oncology Center of Excellence (OCE) began an “innovation challenge” in oncology drug development, what would that look like?
FDA has accepted the Bristol Myers Squibb’s Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20)—herein referred to as “subcutaneous nivolumab”—across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
The Biden administration has—for the second time—delayed the decision on a proposed FDA rule that would ban menthol cigarettes and all flavors in cigars.
FDA has finalized a rule to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years.
FDA issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.
