FDA said grease-proofing materials containing per- and polyfluoroalkyl substances (PFAS) are no longer being sold for use in food packaging in the U.S.
FDA has granted Breakthrough Therapy Designation to Epkinly (epcoritamab-bysp) for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
FDA has accepted a Biologics License Application for Tevimbra (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
In a major breakthrough in cellular therapy, FDA has approved the first tumor-infiltrating lymphocyte therapy for patients with unresectable or metastatic melanoma who have received prior treatment, including with checkpoint inhibitors.
Feb. 16, 2024, is a landmark date in the history of immuno-oncology.
Energy and Commerce Committee Health Subcommittee Ranking Member Rep. Anna G. Eshoo (D-CA), Ranking Member Rep. Frank Pallone, Jr. (D-NJ), and Oversight and Investigations Subcommittee Ranking Member Rep. Kathy Castor (D-FL) wrote to FDA Commissioner Robert M. Califf to urge the agency to move forward with guidance to improve the diversity of populations represented in clinical trials.
FDA approved Tagrisso (osimertinib) with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
FDA has accepted for Priority Review the biologics license application for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma that has progressed after at least three prior therapies.
The FDA Oncology Center of Excellence published its 2023 annual report.
FDA has approved Onivyde (irinotecan liposome) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.
