Gingery, D, Accelerated Approval: US FDA Writing Guidance On What ‘Ongoing’ Means For Confirmatory Trials. Pink Sheet. 15. 11. 2023. Merrill, J.RegeneronOncology Setback Delivered By US FDA Crackdown On Accelerated Approval. Scrip. 25. 03. 2024....
FDA Approvals & Designations in Oncology: February 2025 Highlights Jordyn Sava March 4th 2025 Article Here is a look back on all the FDA happenings from the month of February 2025. Read More FDA Grants Priority Review to TLX250-CDx in Kidney Cancer ...
a bispecific antibody (bsAb) CD20 x CD3, for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). However, the company is continuing to pursue this approval for follicular lymphoma (FL), with an FDA decision expected by ...
2021 FDA approvals: value driven by COVID-19 vaccines. Nat Rev Drug Discov. 2022. https://doi.org/10.1038/d41573-022-00015-3. Wang J, Lozier J, Johnson G, Kirshner S, Verthelyi D, Pariser A, et al. Neutralizing antibodies to therapeutic enzymes: considerations for testing, prevention...
原研机构 Regeneron Pharmaceuticals, Inc. 在研适应症 非在研适应症 SARS-CoV-2 S protein抑制剂 在研机构 Roche Products Ltd. 原研机构 Regeneron Pharmaceuticals, Inc. 在研适应症 新型冠状病毒感染 非在研适应症- 最高研发阶段批准上市 首次获批国家/地区 ...
ETMerck's Keytruda, already boasting some 40 FDA approvals, has picked up a priority review in a proposed new use.The company's filing for the drug as part of a perioperative regimen for patients with resectable locally advanced head and neck squamous cell carcinoma has been accepted for a ...
The target action date for the FDA decision is July 30, 2025, providing a clear timeline for potential approval and commercialization. The BLA resubmission demonstrates strong clinical support, with an overall response rate of 80% in pivotal Phase 1 and 2 trials, highlighting the ...