Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA accepted Hansa Biopharma’s BLA for imlifidase and set a PDUFA action date of Dec. 19, 2026. The filing is backed by Phase 3 ConfIdeS data showing statistically significant efficacy.
Merck is expanding its AI efforts through partnerships with Google Cloud and Mayo Clinic. The company said it will deploy AI across R&D and use multimodal clinical datasets to support drug discovery and precision medicine.
Researchers at the University of Bath reported a bacterial system for producing, stapling, and testing millions of peptide molecules inside living cells. The Cell Chemical Biology study uses a survival-based assay to identify stable, functional peptide candidates.
Sarepta Therapeutics said it will announce first quarter 2026 financial results. The event will be webcast on its investor relations website, with a replay archived for one year.
Two reviews found blockchain may strengthen secure medical data sharing and federated learning in health care. One identified 42 initiatives, while another reviewed over 100 papers from 2018 to 2025.
A $3.2 million research collaboration is developing a drug that directly breaks down MDM2 in triple-negative breast cancer. Early laboratory models showed tumour shrinkage, and the team is studying dosing, safety and performance.
The acting director of the CDC delayed publication of a report showing the COVID-19 vaccine cut emergency department visits and hospitalizations for healthy adults last winter by about half. The Department of Health and Human Services did not immediately respond to request for comment.
The first clinical trial of an AAV gene therapy for type 1 diabetes is set to begin this year. The 52-week phase 1 PROGRESS study will test one-time intramuscular KRIYA-839 in adults with A1c above 7% using automated insulin delivery systems.
MSD signed a Google Cloud agreement worth up to $1 billion and entered an AI-focused R&D collaboration with Mayo Clinic. The deals expand AI use in drug discovery, development and broader operations.
Nature Communications findings showed NR2F6 deletion revived exhausted CAR-T cells and boosted activity against solid tumors. In murine models, modified cells drove tumor regression, prolonged survival and resistance to rechallenge.
Eli Lilly, AbbVie, Vertex, Gilead Sciences and Pfizer were identified as pharmaceutical stocks to watch, with Abbott Laboratories and McKesson appearing on a separate seven-stock list.
A study of 2,282 adults aged 60 and older found anemia was associated with higher Alzheimer’s disease blood biomarkers and a 66% higher chance of developing dementia. The highest risk was seen in participants with both anemia and higher biomarker levels.
Adial Pharmaceuticals completed demonstration batch production for AD04, meeting prespecified specifications and matching the prior Phase 2 dissolution profile. The step enables clinical and registration batch production for the planned Phase 3 trial.
The Veterinary Medicines Directorate will launch a new digital service for reporting animal medicine adverse events on 20 May 2026. The beta service will replace the previous suspended tool and integrate with existing pharmacovigilance processes.
AsedaSciences signed a commercial agreement with Clyde Biosciences to integrate the CellOPTIQ cardiotoxicity screen into its 3RnD platform. The deal adds a validated in vitro CiPA assay for chemical and drug safety assessment.
A study in Cell suggests a urine DNA test may help identify which people with non-muscle invasive bladder cancer are likely to benefit from BCG immunotherapy. The test detected minimal residual disease after surgery and BCG treatment and distinguished recurrence risk based on tumour DNA findings.
Astellas terminated its phase 1 ASP5502 study in Sjögren’s syndrome as Novartis said the FDA granted breakthrough therapy designation to ianalumab. Novartis plans global regulatory submissions from early 2026 after positive phase III data.
Eli Lilly and Co. expanded its collaboration with Hong-Kong listed Insilico Medicine Inc. in a deal worth up to $2.75 billion. The move deepens Lilly's investment in artificial intelligence-driven drug discovery and could broaden its reach into next-generation metabolic therapies.
Diabetes and heart disease can impair sexual function by damaging blood vessels, nerves and circulation. Sexual dysfunction may also be an early warning sign of underlying vascular damage.
Trump’s April 2, 2026 proclamation imposes Section 232 tariffs of up to 100% on patented pharmaceutical imports and ingredients. Generic drugs and biosimilars are excluded.
