Clinuvel Gets EMA Advice for Pivotal Phase III Vitiligo Study
EMA has issued final scientific advice clearing Clinuvel’s pivotal vitiligo trial to use a “totality of evidence” assessment anchored...
Nectero Reports 2-Year Safety and Efficacy Data for AAA
In a 46-patient first-in-human study of small- to medium-sized abdominal aortic aneurysms (AAA), Nectero’s investigational Nectero EAST System delivered...
KOL Event Spotlights Lasofoxifene for Resistant Cancer
Phase 2 signals continue to support lasofoxifene’s pursuit of ESR1‑mutated, ER+/HER2‑ metastatic breast cancer. In ELAINE‑1, lasofoxifene outperformed fulvestrant...
Psyence Biomed Doses First Patient in Adjustment Disorder Trial
Psyence Biomedical has dosed the first patient in its Phase IIb study of NPX-5, a GMP-compliant, nature-derived psilocybin candidate,...
Epitopea Announces New Ovarian Cancer Clinical Trial Approval
Epitopea has secured UK MHRA and Regional Ethics Committee clearance to initiate OVACT, a first‑in‑human Phase 1/1b study of...
When the Trial Says No but the Site Was Never Ready
The THEIA trial's negative alteplase result may reflect site execution failures more than drug biology—a CAPA lesson every ops...
Loper Bright Is Rewriting FDA’s Authority Over Synthetic Biology — Before the Industry Knows It
The Supreme Court's Loper Bright ruling is quietly dismantling FDA's deference-based regulatory hold over synthetic biology, and clinical programs...
Lifestyle Program Improves Brain Health in Cognitive Decline
Interim data from the PREVENTION clinical study report improvements in cerebral blood flow and insulin response among people with...
Maze Therapeutics Announces Sizable $150M Growth Offering
Maze Therapeutics priced a $150 million follow-on, selling 5.54 million shares at $23.50 and issuing 0.85 million pre-funded warrants...
Orion’s ODM-212 Trial for Solid Tumours Starts Phase 1b/2
Orion has opened enrollment for TEADCO, a multicenter, open-label Phase 1b/2 basket trial testing its oral pan-TEAD inhibitor ODM-212...