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Tag Archives: Merck

FDA approves pembrolizumab plus lenvatinib

September 2021—The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) for patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

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FDA approves first vaccine for Ebola virus

February 2020—The U.S. Food and Drug Administration announced the approval of Ervebo (Merck), the first FDA-approved vaccine for the prevention of Ebola virus disease, caused by Zaire ebolavirus, in people 18 years of age and older. Ervebo is administered as a single-dose injection and is a live, attenuated vaccine that has been genetically engineered to contain a protein from the Zaire ebolavirus.

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Keytruda combo gets accelerated approval

December 2019—The Food and Drug Administration granted accelerated approval to the combination of pembrolizumab (Keytruda, Merck) plus lenvatinib (Lenvima, Eisai) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.

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FDA OKs pembrolizumab for treatment of HNSCC

October 2019—The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was approved for use in combination with platinum and fluorouracil for all patients and as a single agent for patients whose tumors express PD‑L1 (combined positive score, ≥1) as determined by an FDA‑approved test.

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Pembrolizumab plus axitinib approved for RCC

June 2019—The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma. Approval was based on Keynote‑426, a randomized, multicenter, open-label trial conducted in 861 patients who had not received systemic therapy for advanced renal cell carcinoma. Patients were enrolled regardless of PD-L1 tumor expression status.

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Put It on the Board, 8/16

August 2016—LabCorp will acquire Sequenom; New York ends state PT services; St. Jude lands CAP ISO 15189 accreditation; Epigenomics’ DNA test included in CRC guideline; OSU to deploy Inspirata digital pathology solution; Mindray’s clinical chemistry analyzer cleared; Successful Keytruda trial stopped early; Top court clarifies autopsy’s place in Texas law; EUA for Siemens Zika assay

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