The Basket Trial Is the New Black — and the FDA Hasn’t Caught Up
Arrowhead Pharmaceuticals' Phase 1 basket trial of zodasiran enrolled five distinct lipid disorder populations under a single protocol —...
Oral Brexanolone’s Phase 3 Failure Exposes a Gap Ketamine Already Fills
Lipocine's LPCN 1154 just failed its Phase 3 trial for postpartum depression, sending shares down 77%. For psychiatrists treating...
The FDA Just Opened a Door in Anal Cancer Trials — And Most Sponsors Don’t Know It’s There
Oncolytics Biotech's Type C meeting request to discuss a single-arm registrational pathway for pelareorep in anal cancer is more...
Minerva Screens First Patient in Phase 3 Schizophrenia Trial
Minerva Neurosciences has screened the first patient in MIN-101C19, a global, confirmatory Phase 3 trial of roluperidone as monotherapy...
Trethera & MGH Launch Clinical Trial for TRE-515 in ALS
In Trethera’s prior expanded access case, treatment with TRE-515 in an 87-year-old patient with advanced ALS was associated with...
Ernexa Therapeutics Advances Toward 2026 Human Trials
Preclinical data from a syngeneic ovarian cancer model showed that Ernexa’s ERNA-101, an engineered induced mesenchymal stem cell therapycell...
The Alzheimer’s Prevention Trial Has No Finish Line — Until Now
A new set of target product profiles published in Nature Medicine attempts to define what a successful preventive Alzheimer's...
Bio Solutions’ Successful Study Advances FDA Drug Screening
Intelligent Bio Solutions completed its initial clinical Cut-off Study for a fingerprint-based codeine screen in 40 adults, finalizing data...
Adagene, Incyte Collaborate on Colorectal Cancer Drug Trial
No new efficacy data accompanied the announcement. Prior signals for the components remain preliminary: muzastotug has shown encouraging responses...
Improved Durability Seen for Muzastotug Combo in CRC Study
Topline data from Adagene’s Phase 1b/2 trial in late-line MSS metastatic colorectal cancer without liver metastases show a dose-dependent...