GSK Secures Approval Yet Refuses to Produce Drug
$GSK is ostensibly the "sponsor" that won the approval but is once again saying it won't produce the drug.
Prasad’s Missteps as CBER Chief Spark Criticism
On Prasad’s last few weeks as CBER chief: 1. It was absurdly inappropriate to bring a large group of reporters together and rail on a pending application “on background” 2. The walk back of the Moderna RTF was a bad...
FDA COO Butler Retires After One Year; Deputy Assumes Role
after just one year in the position, FDA COO Butler will retire, and his deputy will take over in April - https://t.co/9qmmIiuWX2
Immedica Secures Accelerated Approval, Plans PRV Sale
Immedica wins accelerated approval for once-rejected rare disease drug, plans to sell PRV - https://t.co/wU3AfqQzjw
FDA Issues Guidance on New Individualized Therapy Pathway
Building off the Baby KJ success story: FDA unveils long-awaited guidance on new pathway for individualized therapies - https://t.co/Uetp1cGFq2