- In second reversal, FDA gives uniQure a green light to seek accelerated approvalRegulatory flexibility appears to be back on the FDA’s menu following the departures of Marty Makary and Vinay Prasad. At the center of the debate, once again, is the ...Endpoints · 1mo ago↗ source
- STAT+: FDA appears open to Moderna’s flu vaccine ahead of adcommUniQure will submit Huntington's therapy for approval, Eli Lilly buys 4E Therapeutics, and more biotech newsSTAT · 1mo ago↗ source
- STAT+: Pharmalittle: We’re reading about hackers extorting Novo, an FDA about-face, and moreA cyber extortion group claimed to have stolen more than a terabyte of data from Novo Nordisk and said it is exploring selling some of the dataSTAT · 1mo ago