RGX-121 was rejected in early February, with Regenxbio listing the primary reasons given by the FDA as concerns about the ability to properly define a patient population, the use of a natural history ...
While the FDA appears to be adamant that uniQure conduct a sham surgery–controlled Phase 3 trial before AMT-130 can be ...
We're often told to be the bigger person and to forgive quickly to keep the peace. But constantly taking the high road can teach people that your boundaries don't matter. Here are 17 things you're not ...
New drugs and lucrative markets in the US remain crucial to Europe’s pharma sector, as governments approach closer trade with ...
Five years ago, real-time clinical decision support and documentation that writes itself would have sounded like science fiction. Today, these capabilities are shipping in production software. The gap ...
BNY Mellon Small/Mid Cap Growth Fund (Class A shares at NAV) outperformed its benchmark, the Russell 2500 Growth Index, ...
An audio-obsessed tour of 15 U.S.-sold cars with legendary factory soundtracks—Hellcat and Blackwing V8 brutality, GT3 precision, LFA’s 9,000-rpm V10 scream, plus oddball hits like GR Corolla. Built ...
Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.
TD Cowen 46th Annual Health Care Conference March 2, 2026 9:10 AM ESTCompany ParticipantsSean McClain - Founder, CEO, ...
Days after FDA Commissioner Marty Makary appeared to malign uniQure’s AMT-130 in an interview with CNBC, the agency confirmed ...
In a strikingly blunt briefing, a senior FDA official accused uniQure of pushing “distorted” data to mask a “failed” therapy ...
Off-campus mental health resources include a 24/7 hotline, outpatient therapy and an intensive outpatient program.