FDA approves Bristol-Myers Squibb’s Opdivo injection to treat mUC
Bristol-Myers Squibb’s Opdivo injection (nivolumab) has been approved by U.S. FDA for intravenous use in previously treated, locally advanced or metastatic urothelial carcinoma (mUC), a type of bladder cancer. This indication is approved based on tumour response rate and duration of response and its continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. The company received the application priority review and breakthrough therapy designation for Opdivo from the FDA to treat patients with locally advanced or mUC.
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