FDA approval for Opdivo and Yervoy in combination and Opdivo as monotherapy for the treatment of all metastatic melanoma patients, regardless of BRAF mutation status, puts Bristol on equal footing with Merck in the indication, and positions it to take on the BRAF inhibitors.
The latest approval for Bristol-Myers Squibb Co.’s PD-1 inhibitor Opdivo (nivolumab) puts the drug back on equal footing with Merck & Co. Inc.’s Keytruda (pembrolizumab) in melanoma and increases pressure on the marketed BRAF inhibitors.
Opdivo's approval, as monotherapy and in combination with the company’s own CTLA-4 inhibitor Yervoy (ipilimumab), in patients with unresectable or metastatic melanoma was expanded Jan. 23 to include patients with...
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
