Curated news and analysis on clinical trials, drug approvals, and medical research.
Wafik S. El-Deiry highlighted p53 research and the August 2025 approval of dordaviprone/modeyso, the first treatment for diffuse gliomas with H3K27M mutations. Separate posts also described glioblastoma precision oncology discussions and a lifetime achievement award in Mumbai.
GRI Bio discussed positive Phase 2a idiopathic pulmonary fibrosis data for GRI-0621, highlighting biomarker results indicating improvements in fibrosis and lung repair.
Merck reported Phase 2 CADENCE results showing WINREVAIR met the primary endpoint in adults with CpcPH-HFpEF. The company said the data support advancement into a registrational Phase 3 study.
Rua Gold filed a fast-track application for its Auld Creek project in New Zealand’s Reefton Goldfield. A decision is expected within three months, with studies and permitting work advancing in parallel.
Rua Gold submitted a referral application for fast-track permitting for its Auld Creek underground mine and processing plant near Reefton. A decision is expected by mid-July.
Evidence on ketogenic diets remains limited for psychiatric disorders and diabetes, while a systematic review in overweight and obese women with PCOS found significant short-term improvements. Experts said more controlled, long-term studies are needed.
Eli Lilly and Company has agreed to acquire Orna Therapeutics for up to $2.4 billion in cash. The deal includes ORN-252, a clinical-trial-ready CD19-targeting in vivo CAR-T therapy for B cell-driven autoimmune diseases.
BridgeBio Oncology Therapeutics said Bbo-11818 received FDA Fast Track designation for adult patients with advanced KRAS-mutated pancreatic ductal adenocarcinoma. The status may accelerate development and review and allow more frequent FDA communication during clinical trials.
Two osteosarcoma studies identified prognostic immune biomarkers, including serum sB7-H3 and an immune cell infiltration score. Both linked immune features with survival, metastasis and treatment response.
MicroOrganoSpheres predicted treatment success in 83% of 21 advanced colorectal cancer cases, reaching 100% accuracy with primary-tumor samples. The automated test can be performed within days.
A securities class action alleges Corcept misled investors about the regulatory prospects for relacorilant. The suit cites an FDA Complete Response Letter, a 50.4% stock drop, and an April 21, 2026 lead plaintiff deadline.
VYLOY (zolbetuximab-clzb) remains the only approved CLDN18.2-targeted therapy for first-line HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumors. The pipeline is focused on next-generation antibodies, ADCs, CAR-T, NK-cell and bispecific approaches aiming to build on zolbetuximab benchmark data.
Xenon Pharmaceuticals reported positive Phase III X-TOLE2 results for azetukalner in focal onset seizures. The company plans an FDA new drug application in Q3 2026.
Compass Pathways reported positive late-stage COMP360 psilocybin data in treatment-resistant depression and plans FDA talks ahead of a filing between October and December. The update lifted shares across several psychedelics developers.
A cost-effectiveness analysis found home-based anal cancer screening increased participation versus clinic-based screening among sexual and gender minority individuals. The approach remained investigational because the FDA has not approved self-sampling for anal cancer screening.
The Trump administration has agreed to release federal funding for the $16 billion Gateway rail tunnel and Second Avenue Subway Phase 2, ending months-long suspensions that halted work and caused layoffs. Gateway funding had been suspended for over four months, leaving $205 million owed and forcing 1,000 layoffs, while Second Avenue Subway funds were withheld for seven months pending compliance reviews.
India Pharma 2026 will be held April 13-14 in New Delhi with the theme "Discover in India: Leapfrogging Life-Sciences Innovation." The event will focus on R&D, regulation, AI, CRDMO and financing.
Psyence Biomedical Ltd. completes a $5 million share-for-share equity investment in PsyLabs through put option exercise, strengthening their strategic supply relationship. The transaction involves no cash exchange but gives PsyLabs approximately 50% ownership of PBM. The deal aims to secure pharmaceutical-grade psychedelic compound supply for clinical programs.
Oncotelic Therapeutics announced expanded international intellectual property coverage for OT-101 across neurology, oncology and CNS drug-delivery technologies. The company also highlighted biotech valuation trends tied to clinical progress and its 45% stake in GMP Bio.
Kansas City, Missouri, approved a 13-0 ordinance banning synthetic 7-OH and limiting natural kratom sales to adults 21 and older. The law adds sales restrictions, licensing requirements and fines as scrutiny of 7-OH products increases.
