Section
FDA, Congress, and the rules that move the industry.
mFLUSIVA is licensed for adults 50 and older as of 5 August, but the committee that usually turns a license into coverage has not met all year , and flu season is weeks away.
Antitrust regulators are investigating whether mid-sized biopharma acquisitions could suppress early-stage clinical innovation or delay secondary indication trials in rare diseases.
Regulators are requiring confirmatory Phase 3 trials to be actively enrolling before granting accelerated approval, eliminating years of post-market clinical uncertainty.
CMS published maximum fair prices for the initial ten Part D blockbusters, forcing drug developers to re-evaluate small-molecule discovery timelines and indication stacking.