FDA has granted Fast Track designation to CPI-613 (devimistat) for the treatment of acute myeloid leukemia.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Keytruda, Merck's anti-PD-1 therapy, as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
Bayer and Veracyte have entered a collaboration to advance the Precision Oncology Patient Identification Program in thyroid cancer.
Servier has entered into an agreement for the acquisition of Agios Pharmaceuticals' oncology business including its commercial, clinical and research-stage oncology portfolio for up to $2 billion, including an upfront payment of $1.8 Billion and a potential $200 million in regulatory milestone, plus royalties.
Kite, a Gilead Company, and Oxford BioTherapeutics Ltd. have entered into a research collaboration to evaluate five novel targets for a number of hematologic and solid tumor indications.
FDA is issuing a guidance on FDA's enforcement policy regarding certain quality standards requirements under the Mammography Quality Standards Act of 1992.
McKesson and Amgen signed a strategic agreement to improve cancer care in community oncology settings.
FDA has granted accelerated approval to Danyelza (naxitamab-gqgk) 40mg/10ml in combination with granulocyte-macrophage colony-stimulating factor for the treatment of pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
Gavreto (pralsetinib) received FDA approval for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
FDA has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography imaging of prostate-specific membrane antigen positive lesions in men with prostate cancer.
