FDA granted the next-generation selective RET inhibitor EP0031/A400 Fast Track designation for the potential treatment of RET-fusion positive non-small cell lung cancer.
FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma.
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.
Lixte Biotechnology has signed an exclusive patent license agreement with the National Institute of Neurological Disorders and Stroke and NCI.
Exact Sciences Corp. has launched the Riskguard hereditary cancer test in the United States.
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.