While the FDA appears to be adamant that uniQure conduct a sham surgery–controlled Phase 3 trial before AMT-130 can be ...

Psychedelics are a “game changer” in depression care, according to William Blair, but the complicated treatment regimens mean ...

The timing of the partial hold is “odd,” according to analysts at Stifel, who noted that the preclinical data the FDA took ...

Adam Urato, who is currently a vaccine advisor to the CDC, is closely associated with acting CDER director Tracy Beth Høeg ...

Ron, managing partner at FreeMind Group, and Ravi Kiron, managing director at Biopharma Strategy Advisors. We'll be speaking ...

Over half of biopharma professionals would work again at the companies that let them go, according to a BioSpace LinkedIn ...

While an anonymous source tied the closure to shortcomings in the FDA’s new pathway, a spokesperson for the Department of ...

UniQure and REGENXBIO are both dealing with FDA setbacks for their respective gene therapies, as regulatory experts question ...

The FDA last October paused Intellia Therapeutics’ late-stage CRISPR studies after detecting life-threatening enzyme ...

With fresh billions unlocked in the 2026 U.S. budget and mission‑driven family offices recalibrating after a “nuclear winter, ...

In a complete response letter published by the FDA on Monday, the agency said a resubmission for REGENXBIO’s Hunter syndrome ...

Merck’s Keytruda will soon lose exclusivity, just as weight-loss giants Eli Lilly and Novo Nordisk press in with their ...