Girl with Griscelli Syndrome Type II undergoes first haploidentical transplant at Miami hospital
Girl with Griscelli Syndrome Type II receives first haploidentical transplant at Miami hospital, offering new hope for ultra-rare genetic...
Elevar Presents Age-Stratified Camrelizumab-Rivoceranib Data After FDA Rejection
Elevar presents age-stratified camrelizumab-rivoceranib data from Phase 3 CARES-310 after two FDA rejections, signaling potential resubmission strategy.
PMV Pharma’s Rezatapopt Achieves 44% Response Rate in TP53 Y220C Ovarian Cancer
PMV Pharma's rezatapopt achieves 44% response rate in TP53 Y220C ovarian cancer patients, positioning the drug for potential FDA...
Benchmarks Don’t Fail Silently. Agentic AI Does.
Scale AI's CliniCARE-Bench found 34.7% error rates and right-answer-wrong-process failures. The clinical trials field has no governance framework to...
SRD-002 Gene Therapy Shows Sustained HFpEF Improvement at 12 Months
SRD-002 gene therapy shows sustained HFpEF improvement at 12 months with 80% PCWP normalization from a single intracoronary dose.
Stop Writing ‘Routine Labs.’ Every Lab Line Needs Its Own Coverage Citation
A CBC isn't covered because it's routine. It's covered because NCD 190.15 says when. Here's how citation-level MCAs survive...
Orexo’s $4 Million DOJ Settlement Is Deliberately Vague — and That Vagueness Is the Story
Orexo AB settled a 6-year DOJ opioid-marketing investigation for $4M, but the press release names no conduct, no victims,...
Nature Medicine’s 38,753-Patient HF Synthesis Signals a Replicable Model for RWE-Driven Label Expansion Without New RCTs
A 38,753-patient cross-trial synthesis in Nature Medicine maps short-term safety of HF combination therapies—signaling how sponsors can use pooled...
Astellas donates tacrolimus to U.S. API reserve, strikes pricing deal
Astellas donates tacrolimus active pharmaceutical ingredient to U.S. Strategic API Reserve and strikes voluntary Medicaid pricing agreement with government.
Canada’s Drug Agency Issues Positive Reimbursement Recommendation for Lecanemab
Canada's drug agency issues positive reimbursement recommendation for lecanemab after reversing its February rejection, opening access for patients with...