In anticipation of an infusion of funds from Congress, NCI is developing a blueprint for a comprehensive cancer data federation—starting with pediatric cancer.
Device manufacturers looking to market surgical tools for use in the prevention or treatment of cancer may now be required to study long-term oncologic endpoints in surgical trials, according to a safety communication published by FDA on Feb. 28.
The decision to double the budget of the National Institutes of Health should be easy, because it will save lives and save our economy simultaneously. The case for NIH is overwhelming, and there is broad bipartisan congressional support. So why is it so challenging?
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.
FDA has approved Cablivi (caplacizumab-yhdp) injection in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending Vizimpro (dacomitinib) 45 mg, as monotherapy, be granted marketing authorization in the European Union for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor-activating mutations. The CHMP's opinion will now be reviewed by the European Commission
Genentech has submitted a supplemental Biologics License Application to the FDA for Kadcyla (ado-trastuzumab emtansine) for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment.
Merck KGaA and GSK have agreed to jointly develop and commercialize M7824 (bintrafusp alfa). M7824 is an investigational bifunctional fusion protein immunotherapy that is currently in clinical development, including potential registration studies, for multiple difficult-to-treat cancers.
FDA has initiated enforcement action against several retail locations of Walgreen Co. and Circle K Stores Inc. for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors.
Researchers at Georgetown Lombardi Comprehensive Cancer Center released a study that may show immunotherapy offers similar benefit to cancer patients living with HIV.
