FDA nod to first-ever treatment for deadly post-transplant complication TA-TMA
The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement
The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement
Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%
The one-time CAR T cell infusion now becomes the first and only therapy of its kind cleared for this patient population
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
The combination is approved for advanced endometrial carcinoma that is pMMR or not MSI-H and has progressed after prior systemic therapy
Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
Objective response rate of 54.8% seen with Daiichi Sankyo and Merck’s ifinatamab deruxtecan at 12 mg/kg dose in pretreated patients
Second FDA approval for KRAZATI - reinforcing its potential across tumor types
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