Clayton, Dubilier & Rice funds, the Merck Global Health Innovation Fund (Merck GHI), and McKesson Ventures are investing in M2Gen, an oncology data and informatics platform focused on transforming cancer care, in partnership with its existing shareholders.
FDA has approved Fotivda (tivozanib), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
FDA has granted accelerated approval to Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Health Canada has approved Keytruda (pembrolizumab), for the first-line treatment, as monotherapy, for adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
Surface Oncology and Merck have entered into a clinical trial collaboration to evaluate the safety and efficacy of combining Surface’s SRF388, an investigational antibody therapy targeting IL-27, with Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy.
Syapse has renewed its strategic collaboration with Pfizer.
FDA has granted regular approval to Lorbrena (lorlatinib) for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, detected by an FDA-approved test.
FDA has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device that can help facilitate transvaginal hysterectomy in certain patients.
FDA has granted accelerated approval to Pepaxto (melphalan flufenamide) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a second indication for Sarclisa (isatuximab), in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.