Opdivo (nivolumab) in combination with Yervoy (ipilimumab) received FDA approval for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery.
Regeneron has submitted a request to FDA for Emergency Use Authorization approval for the
FDA has issued draft guidance encouraging the inclusion of premenopausal women in breast cancer clinical trials that investigate the efficacy of hormonal drug and biological products.
FDA has granted Rare Pediatric Disease Designation for IVT-8086 for the treatment of Osteosarcoma.
Celyad Oncology SA, a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell therapies for cancer, has entered into a clinical trial collaboration with Merck & Co., Inc., through a subsidiary.
Researchers affiliated with the Cancer Center at Illinois discovered a novel small molecule compound that is now the subject of a new global licensing agreement between the pharmaceutical company Bayer AG and the cancer drug development company Systems Oncology LLC.
Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, and US Oncology Research, one of the largest community-based oncology site management organizations in the U.S., announced a collaboration to utilize the US Oncology Research Selected Trials for Accelerated Rollout (STAR) program for patient enrollment in the registration-enabling Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 gene fusion.
The Reagan-Udall Foundation for the FDA, with input from experts at FDA, has introduced an Expanded Access eRequest app to streamline expanded access for individual patients in non-emergency settings.
FDA has accepted the Biologics License Application for idecabtagene vicleucel (ide-cel; bb2121) as Priority Review.
Agenus Inc. has begun the rolling submission of its Biologics License Application FDA for balstilimab alone for the treatment of recurrent/metastatic cervical cancer.
