TrumpRX and DTC sales may expand prescription drug access, but they will not solve the affordability crisis by themselves.
Center for Biologics Evaluation and Research Director Vinay Prasad will exit the FDA for the second time after a controversial run that saw the oncologist butt heads with colleagues and ruffle ...
Adam Urato, who is currently a vaccine advisor to the CDC, is closely associated with acting CDER director Tracy Beth Høeg ...
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 ...
UniQure’s Path for Huntington’s Gene Therapy Clouded by Ethical Questions as Potential Phase 3 Looms
While the FDA appears to be adamant that uniQure conduct a sham surgery–controlled Phase 3 trial before AMT-130 can be ...
UniQure does not have to drill placebo burr holes in the skulls of patients with Huntington's disease, an unnamed FDA senior official said on Thursday. Instead, the company would anesthetize them and ...
Ron, managing partner at FreeMind Group, and Ravi Kiron, managing director at Biopharma Strategy Advisors. We'll be speaking ...
Servier will pick up Ojemda, which received FDA approval in 2024 to treat pediatric glioma. The drug clocked sales of $155 million for Day One Biopharmaceuticals in 2025.
While an anonymous source tied the closure to shortcomings in the FDA’s new pathway, a spokesperson for the Department of ...
Zealand Pharma’s shares fell 32% in early morning trading Friday after its Roche-partnered asset petrelintide failed to meet investor expectations in a mid-stage clinical trial.
The FDA last October paused Intellia Therapeutics’ late-stage CRISPR studies after detecting life-threatening enzyme ...
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