Curated news and analysis on clinical trials, drug approvals, and medical research.
Longeveron's DMC recommended completing the Phase 2b ELPIS II HLHS trial with no safety concerns; top-line results expected August 2026. The company also appointed a new CEO and announced cost-cutting measures.
University of Galway researchers identified that targeting GABA signaling, specifically α5-GABA A receptors, can restore neural balance and improve memory in Alzheimer's disease models, offering a potential new therapeutic approach distinct from current excitatory-focused treatments.
MEDIPOST treated the first U.S. participant in a Phase III trial of its umbilical cord blood-derived MSC therapy for knee osteoarthritis. The FDA agreed the single pivotal study, supported by prior trials in South Korea and Japan, can support a planned BLA filing.
FDA clears SkinStylus for periorbital wrinkles across all skin types; accepts Biofrontera's sNDA for Ameluz PDT in superficial BCC with a September 2026 PDUFA date; Belite Bio completes rolling NDA submission for tinlarebant in Stargardt disease.
Compass Pathways reports six-month data from its second Phase III COMP006 trial of COMP360 psilocybin for treatment-resistant depression, showing 39% of patients achieved clinically meaningful response maintained through 26 weeks. NDA submission expected in Q4 2026.
Two studies show exercise benefits mental health: one finds exercise programs help smokers quit and reduce cravings for up to 30 minutes; another finds high-intensity exercise outperforms relaxation techniques for panic disorder relief.
Vertex's Phase 3 RAINIER trial of povetacicept in IgA nephropathy met its primary endpoint with a 52% UPCR reduction. The FDA granted rolling review, and Vertex plans full BLA submission by end of March. Shares rose on the news and analyst upgrades.
Novartis acquires UK biotech Myricx Bio for up to $1.5B, gaining a novel NMTi ADC payload platform and two lead assets targeting B7-H3 and HER2. The deal includes $1.1B upfront with $400M in milestones, expected to close in H2 2026.
New court documents link the Project South police corruption probe to alleged Ryan Wedding drug ring associate Gurpreet Singh, while separate U.S. filings accuse "cocaine lawyer" Deepak Paradkar of helping Wedding's organization.
Anthropic announced it will run its own preclinical drug-discovery programs for neglected and rare diseases and launched Claude Science, an AI workbench for researchers. The company has not named specific diseases or detailed how it would bring candidates to market.
The FDA will allow food makers to claim "no artificial colors" as long as dyes are not petroleum-based, even if products contain titanium dioxide. Health experts warn the labeling deceives consumers, as naturally derived additives like titanium dioxide pose health risks and remain unregulated.
Bayer outlined its 2030 growth strategy at Pharma Media Day 2026, driven by AI partnerships, precision medicine, and a strengthened pipeline. The company aims for mid-single-digit growth from 2027 and 30% margins by 2030.
ASH has published new clinical practice guidelines for frontline and relapsed/refractory ALL management in adolescents and young adults, endorsing pediatric-inspired regimens, asparaginase therapy, and immunotherapy over traditional chemotherapy.
The U.S. five-year cancer survival rate reached 70% in 2025, creating 18.6 million survivors. Health systems are expanding survivorship care using advanced practice providers and investing over $4 billion in oncology infrastructure to meet growing demand.
Two new studies advance Lyme disease research: anti-lipid antibodies may enable earlier diagnosis and detect persistent symptoms, while cell wall changes in Borrelia burgdorferi offer insights into Lyme arthritis pathogenesis and potential treatment targets.
Unicycive Therapeutics received an FDA Complete Response Letter for its oxylanthanum carbonate NDA resubmission due to third-party manufacturing deficiencies. The FDA raised no efficacy or safety concerns and requested no new data. Labeling discussions are ongoing.
PCF invests $6.3M in 31 Young Investigator Awards, supports Creativity Awards, and hosts Home Run Challenge 2026 to raise awareness. The foundation has contributed to 15 FDA-approved therapies over its 30-year history.
A living insulin implant from Technion researchers achieved one year of steady blood sugar control in diabetic mice, while millions worldwide still lack access to insulin medication. Animal trials showed beta cells could auto-dose insulin, though immune barriers remain before human trials. Meanwhile, only about half of type 2 diabetes patients globally have access to needed insulin, with the problem affecting both low- and high-income countries.
Scientists have identified SLAMF6 as a key suppressor of T cell immunity against cancer and developed monoclonal antibodies that neutralize it in mice, published in Nature. Biotechnology company Replimune Group has reported its 2026 financial position, with a market value of approximately $234.5 million and ongoing clinical trials.
Grünenthal has successfully completed a Phase I trial for its proprietary nociceptin receptor (NOP) agonist, demonstrating safety and tolerability in 113 healthy volunteers. The company plans to advance the novel pain therapy into a Phase II trial later this year, with results expected in the second half of 2027.
