Curated news and analysis on clinical trials, drug approvals, and medical research.
Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, will depart the agency by the end of April to return to an academic role at the University of California San Francisco.
The phase 3 OCEANIC-STROKE trial of 12,327 patients showed asundexian, an oral Factor XIa inhibitor, reduced ischemic stroke recurrence by 26% when added to standard antiplatelet therapy, with no increase in major bleeding events.
Incyte received a Complete Response Letter from the FDA for Zynyz in lung cancer due to third-party manufacturing issues, while the EMA recommended approval for the drug in anal cancer treatment based on Phase 3 trial data.
Moffitt Cancer Center researchers published findings on plant-based diets and cancer risk, identified spatial tumor-immune patterns predicting immunotherapy response, and hosted a summit on engineering-driven cancer research innovations.
New research highlights circulating tumor DNA as a prognostic tool in early-stage triple-negative breast cancer, while leronlimab demonstrates long-term survival signals in heavily pretreated metastatic patients through CCR5 receptor blockade.
The FDA has denied or discouraged at least eight drug applications in the past year, including treatments for rare diseases, raising concerns about regulatory consistency and the future of experimental therapies.
Novartis AG announced at its March 6, 2026 AGM a 5.7% dividend increase to CHF 3.70 per share for 2025, marking the 29th consecutive annual increase with a 3.0% yield, payable from March 12, 2026.
New research examines both the long-term biological aging effects of childhood cancer treatments and proposes alternative treatment sequencing strategies to prevent tumor resistance and improve cure rates.
Obinutuzumab demonstrated superior efficacy in two separate phase 3 trials for systemic lupus erythematosus and primary membranous nephropathy, with statistically significant improvements in remission rates and disease response measures.
Zealand Pharma's petrelintide achieved up to 10.7% average weight loss after 42 weeks in a 493-patient phase 2 trial, with placebo-like tolerability but lower efficacy than competing amylin drugs, causing Zealand shares to drop 34%.
Dyne Therapeutics is preparing a U.S. Accelerated Approval submission for z-rostudirsen in Duchenne muscular dystrophy and gearing up for a Phase 3 trial of z-basivarsen in myotonic dystrophy, while scaling operations to support potential commercialization.
New research links GLP-1 drugs like Ozempic to increased scurvy risk through appetite suppression and poor nutrition. University of Florida researchers are testing a GLP-1 implant for obese cats as feline obesity affects nearly 60% of US cats.
Genentech announced positive Phase II results for petrelintide, showing up to 10.7% mean weight loss versus 1.7% placebo at week 42 in people with overweight and obesity, with placebo-like tolerability.
South Africa is working to identify local manufacturers for lenacapavir, a twice-yearly injectable HIV prevention drug that showed near-perfect efficacy in clinical trials. Kenya has already received 21,000 doses of the medication.
Researchers at the National University of Singapore have identified protein tyrosine phosphatase 1B (PTP1B) as a molecular switch that regulates immunogenic cell death in cancer cells, offering a new target for chemoimmunotherapy development.
New research reveals how GLP-1 receptor agonists promote pancreatic health through gene expression changes and interact bidirectionally with gut microbiome, while real-world users report unexpected lifestyle changes alongside weight loss.
Outlook Therapeutics conducted a Type A meeting with the FDA to discuss the December 30, 2025 Complete Response Letter for ONS-5010/LYTENAVA™, focusing on substantial evidence of effectiveness and potential regulatory paths forward.
Genentech announced positive Phase II results for CT-388, a dual GLP-1/GIP receptor agonist, showing 22.5% placebo-adjusted weight loss at 48 weeks in people with obesity. The treatment was well-tolerated with low discontinuation rates.
Roche announced positive phase II results for obesity drug petrelintide showing 10.7% weight reduction, while the FDA set a December 18 decision date for breast cancer drug giredestrant.
The FDA has accepted Hansa Biopharma's Biologics License Application for imlifidase, a desensitization treatment for highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, with a PDUFA date of December 19, 2026.
