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.
The Trump administration did exactly what it said it would do to disorient anyone involved in making policy or touched by it. The president and his crew have “flooded the zone”—the term and the image are theirs, as is the strategy of dropping a flurry of executive orders and memoranda that shake the foundations of the American system of government, raising questions of legality and constitutionality, and, above all, making it a challenge for anyone to see the entire picture and think strategically.
