WebMar 22, 2024 · Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch … WebApr 6, 2024 · AbbVie Inc and partner Johnson & Johnson intend to voluntarily withdraw the accelerated approvals of their Imbruvica drug in the U.S. for patients with certain types of blood cancer, the companies ...
JNJ, AbbVie plan to pull US accelerated approvals for some blood cancer …
WebFeb 23, 2024 · In proposing to withdraw the drug, CDER cited the failed confirmatory trial as well as the “integrity” of the accelerated approval process. (Also see “Accelerated Approval: US FDA Request For Makena’s Withdrawal Goes Beyond Failed Confirmatory Trial” – Pink Sheet, 5 Oct, 2024.) Opdivo Holds New Record For Time To Removal WebApr 11, 2024 · Intent to voluntarily withdraw indications for the accelerated approval of ibrutinib (Imbruvica) in previously treated mantle cell lymphoma (MCL) and marginal … sql server convert numeric to time
Genentech Voluntarily Withdraws Atezolizumab FDA Accelerated Approval ...
WebJan 30, 2024 · A biologics license application for cemiplimab (Libtayo) for the second-line treatment of advanced cervical cancer was voluntarily withdrawn following discourse with the FDA, according to a press release from Regeneron Pharmaceuticals. 1 The regulatory decision was made after Regeneron, Sanofi, and the FDA did not align on specific post … WebLed to withdrawal of FDA approval of rucaparib as treatment for germline or somatic BRCA-associated ovarian cancer patients with 2+ prior lines of therapy Overall survival data from SOLO3: Reduced overall survival in subgroup of patients who had 3+prior lines and received treatment with olaparib 6 WebMar 3, 2024 · On 1 March, Merck announced the voluntary withdrawal of its Keytruda (pembrolizumab) immunotherapy for the treatment of patients with metastatic small cell … sheri t kelly arlington wa