Curated news and analysis on clinical trials, drug approvals, and medical research.
Researchers at Washington University in St. Louis have adapted CAR-T immunotherapy to target aggregated amyloid-beta in mice, with transient CAR expression clearing brain plaques. The approach uses CD4+ T cells engineered with receptors based on lecanemab antibody sequences.
The FDA will now require only one adequate and well-controlled clinical trial, combined with confirmatory evidence, to approve new drugs, ending its longtime two-study standard dating back to the 1960s.
Phase 1/2 MARINA trial results published in NEJM show del-desiran achieved approximately 40% reduction in toxic DMPK mRNA in muscle tissue and improvements in myotonia and functional measures in myotonic dystrophy type 1 patients, with acceptable safety profile.
National Institutes of Health Director Jay Bhattacharya will serve as acting director of the Centers for Disease Control and Prevention following Jim O'Neill's departure. Bhattacharya will oversee both agencies simultaneously as the CDC faces significant instability.
RCL Homestead Bay Limited received fast-track approval to construct 2,800 residential homes and a commercial retail precinct in Queenstown. The project is estimated to contribute $720.3 million to GDP and support around 4,420 jobs during construction.
Pivya (pivmecillinam) is now available in the US for treating uncomplicated urinary tract infections in adult female patients, based on three phase 3 trials showing efficacy against susceptible bacterial isolates.
The FDA has accepted for Priority Review Bristol Myers Squibb's New Drug Application for iberdomide in combination with daratumumab and dexamethasone for relapsed or refractory multiple myeloma, with a target decision date of August 17, 2026.
Moderna announced the FDA will consider approving its mRNA-based flu vaccine for older adults after resolving a dispute over clinical trial design. The vaccine showed 34.5% higher efficacy than standard flu shots in trials.
Hansa Biopharma announced on February 18, 2026 that the FDA has accepted its Biologics License Application for imlifidase, supported by positive Phase 3 ConfIdeS trial results in highly sensitized kidney transplant patients.
ImmunityBio has partnered with Accord Healthcare to expand access to Anktiva across 30 countries following conditional EU authorization. The company established an Irish subsidiary to support European distribution and commercialization.
A randomized trial found that men with prostate cancer treated with the GnRH agonist leuprolide experienced significantly more coronary artery plaque progression than those receiving the GnRH antagonist relugolix, suggesting a biological mechanism for cardiovascular risk differences between ADT drug pathways.
Zsofia K. Stadler, MD, has been appointed as the next Editor-in-Chief of JCO Precision Oncology, effective July 1, 2026. She is an Attending Physician and Clinic Director at Memorial Sloan Kettering Cancer Center.
The European Commission granted conditional marketing authorization for ANKTIVA in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer, expanding the therapy's availability to 33 countries across four regulatory jurisdictions.
The global oncology market is projected to grow from $280 billion in 2026 to $748 billion by 2035 at 11.54% CAGR, driven by rising cancer incidence, precision medicine expansion, and strong immunotherapy pipelines across multiple tumor types.
Sift Biosciences, a UC Berkeley spinout, closed an oversubscribed $3.7 million pre-seed financing to advance its AI-driven peptide immunotherapy platform targeting immunologically "cold" solid tumors.
Ankyra Therapeutics announced preclinical data on ANK-203, a first-in-class anchored immunotherapy using monoclonal antibody CD137, showing strong anti-tumor activity with no observed systemic toxicity at the AACR Immuno-Oncology Conference.
The FDA will host Rare Disease Day 2026 on February 23, focusing on patient engagement and accelerating treatment development. The agency released its 2026 Strategic Agenda for the Rare Disease Hub, outlining new regulatory pathways and coordination efforts.
DeepRare, a multi-agent AI system, demonstrated exceptional performance in diagnosing rare diseases across 2,919 conditions, achieving 70.6% accuracy with genomic data and outperforming existing clinical tools in international testing.
Moderna and Merck have begun recruiting for a Phase 2 trial testing V940, an mRNA-based personalized cancer vaccine, combined with Keytruda and chemotherapy as first-line treatment for metastatic squamous non-small cell lung cancer.
AstraZeneca has completed a Phase IIb heart failure trial for AZD5462, finished a real-world breast cancer study in Brazil, and is recruiting for an observational COPD study in heart clinic patients.
