Curated news and analysis on clinical trials, drug approvals, and medical research.
AusBiotech signed an MOU with Proto Axiom for a coordinated 2026 investor-focused event calendar. It also expanded its Medicines Australia partnership for women’s leadership events in Sydney.
Drug candidates designed via generative artificial intelligence are achieving a 90% success rate in Phase I safety trials in early 2026, nearly double the historical industry average of approximately 50%, while compressing development timelines from six years to under 18 months.
The FDA issued early alerts for three medical device safety issues: Abiomed heart pump purge cassettes with leak risks, Trividia blood glucose monitors with misleading error instructions, and Medline homecare beds with fire and entrapment hazards.
Rare disease drug developers face significant funding challenges as traditional investment models prioritize larger patient populations, while diagnostic delays prevent patients from accessing emerging therapies including gene therapies that have reached approval in recent years.
Researchers developed pancreatic-targeted lipid nanoparticles (AH-LNP) that enable precise mRNA delivery to the pancreas through capsule-filter-mediated accumulation. The platform demonstrated efficacy in genome editing and cancer immunotherapy across multiple animal models including non-human primates.
Longeveron Inc. announced Phase 2b clinical trial results published in Cell Stem Cell showing laromestrocel improved physical condition in patients with age-related frailty after nine months compared to placebo.
A clinical trial shows baduanjin, a traditional Chinese mind-body practice, reduces blood pressure by 3-5 points, comparable to first-line medications and brisk walking, with effects sustained for one year.
The FDA has approved a new monthly dosing schedule for Johnson & Johnson's Rybrevant Faspro combined with Lazcluze for first-line treatment of advanced EGFR-mutated non-small cell lung cancer, allowing patients to transition to monthly dosing as early as week five.
The global stem cell therapy market is projected to grow from $18.13 billion in 2025 to $59.70 billion by 2035 at a 12.66% CAGR, driven by chronic disease prevalence and regenerative medicine advances.
A Lancet study of 1.1 million people found that 65% of those initially hesitant about COVID-19 vaccines went on to get vaccinated, with concerns about mRNA technology and safety declining as evidence accumulated during the rollout.
Cellectar Biosciences said it will report full-year 2025 financial results and provide a corporate update on March 4, 2026. The company also shared conference call, webcast, and replay details.
Recent advances in chimeric antigen receptor cell therapies highlight improved designs for CAR-T and CAR-NK treatments, with new strategies addressing efficacy and safety challenges in both hematologic and solid tumors.
Novo Nordisk announced it will reduce list prices of Wegovy, Ozempic, and Rybelsus by 35% to 50% to $675 monthly starting in 2027, aiming to regain market share from rival Eli Lilly and improve access for high-deductible patients.
New target trial emulation study finds GLP-1 receptor agonists associated with lower heart failure hospitalization risk versus DPP-4 inhibitors and similar risk to SGLT-2 inhibitors in type 2 diabetes patients.
Novartis announced positive Phase III ALIGN results for Vanrafia in IgA nephropathy and plans to build a new radioligand therapy manufacturing site in Denton, Texas, operational by 2028.
The iShares Biotechnology ETF (IBB) has gained 27.39% over the past year as of February 25, 2026, with over $8.64 billion in assets under management and a 0.44% expense ratio.
The FDA accepted Viatris' application for phentolamine ophthalmic solution 0.75% to treat presbyopia, with a decision expected October 2026. Separately, the agency approved Yuvezzi, a once-daily combination eye drop for age-related near vision loss.
Industry leaders highlight advances in AI-enabled trial monitoring, real-world data interoperability, and protocol-driven eSource systems, while emphasizing the need for community engagement in diversity efforts and addressing operational risks in rare disease trials.
The FDA has announced a major policy shift ending the "two-trial dogma," allowing drug approvals based on one adequate and well-controlled study plus confirmatory evidence, with heightened focus on study design quality.
The FDA approved BYSANTI (milsaperidone) for bipolar I disorder and schizophrenia in adults, and accepted Vanda's BLA filing for imsidolimab to treat Generalized Pustular Psoriasis with a target action date of December 12, 2026.
