Curated news and analysis on clinical trials, drug approvals, and medical research.
Ocular Therapeutix announced positive topline results from SOL-1, its Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration, meeting primary and durability endpoints with high statistical significance.
Researchers from Stanford Medicine developed an injection that reprograms cells to regrow cartilage by blocking the protein 15-PGDH, offering potential treatment for osteoarthritis from aging or injury.
The FDA issued a Complete Response Letter for Disc Medicine's bitopertin application for erythropoietic protoporphyria, citing concerns over surrogate endpoints despite review under the accelerated approval pathway and Commissioner's National Priority Voucher pilot program.
The FDA declined to approve Disc Medicine's bitopertin for erythropoietic protoporphyria on February 13, 2026, citing insufficient evidence linking biomarker reductions to clinical benefit. The company will pursue traditional approval using Phase 3 APOLLO trial data expected in Q4 2026.
Longeveron Inc. appointed Stephen H. Willard as CEO effective February 11, 2026, replacing interim CEO Than Powell. The appointment comes as the company expects top-line results from its pivotal Phase 2b trial for Hypoplastic Left Heart Syndrome in Q3 2026.
Homologous recombination deficiency testing and molecular profiling are reshaping treatment strategies for advanced ovarian cancer, guiding PARP inhibitor and bevacizumab maintenance decisions in newly diagnosed patients.
The Andrew Hillman Grant for Biotech awards $1,000 to undergraduate students pursuing biotechnology careers. Applications are due June 15, 2026, with the winner announced July 15, 2026.
Nektar Therapeutics completed a $460 million public offering on February 13, 2026, selling 7.6 million shares of common stock and pre-funded warrants. The clinical-stage biotechnology company is developing immunotherapy treatments for autoimmune diseases.
Retrospective analysis of the ZUMA-2 trial found that previous ibrutinib exposure was associated with improved progression-free survival after brexucabtagene autoleucel treatment in mantle cell lymphoma patients, though with increased toxicity.
Research shows TET2-driven clonal hematopoiesis improves immune checkpoint blockade efficacy in solid tumors, while separate studies identify new immune pathways in childhood brain cancers and mechanisms behind immunotherapy resistance.
Eli Lilly acquired Orna Therapeutics for $2.4 billion and announced multiple partnerships while investing in AI drug discovery infrastructure, including building the industry's largest AI supercomputer to boost clinical trial success rates.
The CDC is investigating a multistate outbreak of extensively drug-resistant Salmonella Newport with an NDM-1 gene linked to Rosabella moringa powder capsules, marking the first documented outbreak of Salmonella with an NDM-1 gene in the United States.
The FDA rejected Disc Medicine's bitopertin for erythropoietic protoporphyria, citing uncertainties about clinical benefit despite the drug receiving a priority review voucher. The company will pursue traditional approval with Phase 3 data expected in late 2026.
The FDA issued a Complete Response Letter for bitopertin in erythropoietic protoporphyria, acknowledging the drug lowers PPIX levels but requiring Phase 3 APOLLO trial results to demonstrate clinical benefit before approval.
The FDA issued a Complete Response Letter for Disc Medicine's bitopertin New Drug Application for erythropoietic protoporphyria, requiring results from the ongoing Phase 3 APOLLO study before making an approval decision. Topline data is expected in Q4 2026.
MEDIPOST has submitted an investigational new drug amendment to the FDA to initiate a Phase III trial of its umbilical cord blood-derived mesenchymal stem cell therapy for knee osteoarthritis, with patient enrollment expected in the first half of 2026.
Odisha introduces a biotechnology research fellowship offering Rs 30,000 monthly to 20 PhD scholars annually, while the state budget approves establishment of dedicated biotechnology research centers and an innovation mission.
Bristol-Myers Squibb received orphan drug designation from the FDA on Feb. 13 for a treatment targeting follicular lymphoma, a type of cancer affecting the lymphatic system.
Researchers have developed modified CAR T cells that overcome prostaglandin E2 suppression in solid tumors and a selective therapy targeting IGHV4-34 that spares healthy immune cells, addressing key limitations in current treatments.
A Philadelphia jury found Johnson & Johnson liable for a woman's ovarian cancer death linked to talc-based baby powder, awarding $250,000 in damages. The verdict marks the first plaintiffs' win in Philadelphia's talc mass tort litigation.
