FDA rule focuses on the safety and effectiveness of LDTs

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FDA has finalized a rule to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years. 

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FDA has accepted the Bristol Myers Squibb’s Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20)—herein referred to as “subcutaneous nivolumab”—across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.