{"slug":"fda-oce-applicant","tag":"fda-oce-applicant","variants":["fda-oce-applicant"],"description":"No description yet","count":9,"kinds":{"company":9},"related":[],"records":[{"id":"coherus","kind":"company","name":"Coherus BioSciences","route":"/companies/coherus/","tldr":"Coherus is a Californian company that grew up on biosimilars and now holds the US rights to toripalimab, the anti-PD-1 antibody approved in 2023 for nasopharyngeal carcinoma, the first FDA approval for that cancer."},{"id":"geron","kind":"company","name":"Geron Corporation","route":"/companies/geron/","tldr":"Geron is the Californian company behind imetelstat, the first telomerase inhibitor to reach approval, cleared by the FDA in 2024 for lower-risk myelodysplastic syndromes with transfusion-dependent anaemia."},{"id":"checkpoint-therapeutics","kind":"company","name":"Checkpoint Therapeutics","route":"/companies/checkpoint-therapeutics/","tldr":"Checkpoint Therapeutics developed cosibelimab, an anti-PD-L1 antibody approved by the FDA in December 2024 for advanced cutaneous squamous cell carcinoma, and was acquired by Sun Pharma in 2025."},{"id":"xcovery","kind":"company","name":"Xcovery","route":"/companies/xcovery/","tldr":"Xcovery is the Florida company that developed ensartinib, an ALK inhibitor approved by the FDA in December 2024 for ALK-positive non-small-cell lung cancer, partnered with Betta Pharmaceuticals in China where it was approved first."},{"id":"medac","kind":"company","name":"medac","route":"/companies/medac/","tldr":"medac is a German family-owned pharmaceutical company whose alkylating agent treosulfan, long used in Europe, was approved by the FDA in 2025 as conditioning treatment before stem cell transplantation in acute myeloid leukaemia and myelodysplastic syndromes."},{"id":"gamida-cell","kind":"company","name":"Gamida Cell","route":"/companies/gamida-cell/","tldr":"Gamida Cell developed omidubicel, the nicotinamide-expanded cord blood therapy approved by the FDA in 2023 to speed neutrophil recovery after transplant in patients with blood cancers."},{"id":"mesoblast","kind":"company","name":"Mesoblast","route":"/companies/mesoblast/","tldr":"Mesoblast is an Australian cell therapy company whose remestemcel-L became in December 2024 the first mesenchymal stromal cell therapy approved by the FDA, for children with steroid-refractory acute graft-versus-host disease."},{"id":"delcath","kind":"company","name":"Delcath Systems","route":"/companies/delcath/","tldr":"Delcath makes the Hepzato Kit, the melphalan percutaneous hepatic perfusion system approved by the FDA in 2023 for uveal melanoma that has spread to the liver, and sells the same device in Europe as Chemosat."},{"id":"merck-kgaa","kind":"company","name":"Merck KGaA (EMD Serono)","route":"/companies/merck-kgaa/","tldr":"Merck KGaA of Darmstadt, which trades as EMD Serono in North America, sells the anti-PD-L1 antibody avelumab, cetuximab outside the United States and the MET inhibitor tepotinib, and bought SpringWorks Therapeutics in 2025 to add nirogacestat and mirdametinib for rare tumours."}]}