Colorectal, Bladder Cancer Therapies Are Top Prospects For April US FDA Approvals
Sanofi’s next-generation meningococcal vaccine, broader use of Bristol-Myers Squibb’s Reblozyl move toward approval; United Therapeutics foreshadows Trevyent regulatory difficulties.
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In a podcast interview, Janet Woodcock talks about review deadlines, prioritizing pre-approval inspections, and how advisory committees could be held in an era of social distancing.
Assessment work also isn’t slowing down, the new and generic drug office directors said in an interview, but approval data offers a note of concern.
Daily round-up from the J.P. Morgan Healthcare Conference in San Francisco: There was no big M&A, but biopharma CEOs discussed deals they're pursuing. Also, Novartis's Zolgensma reimbursement insights, Sarepta's third DMD filing, Bristol's post-merger progress and more highlights.