Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA has accepted Savara's Biologics License Application for Molbreevi in autoimmune pulmonary alveolar proteinosis, granted priority review, and set a PDUFA action date of August 22, 2026. The company plans to file marketing authorization applications in the EU and UK by the end of March.
Moderna's mRNA-1010 seasonal influenza vaccine enters FDA review following a revised approach that splits approval pathways by age group, with a decision expected by August 2026.
Australian regulators confirmed counterfeit GLP-1 products contain no active ingredients, while U.S. authorities escalate enforcement against compounded weight-loss drugs as Novo Nordisk sues telehealth company Hims & Hers.
Over 100 children with rare diseases in India have exhausted the Rs 50 lakh financial assistance limit under the National Policy for Rare Diseases 2021, forcing treatment halts and prompting urgent appeals for continued support.
Phase 3 BREAKWATER trial shows encorafenib plus cetuximab and chemotherapy achieved 30.3 months median overall survival versus 15.1 months with standard therapy in previously untreated BRAF V600E-mutant metastatic colorectal cancer.
Union Minister Dr. Jitendra Singh announced the first national call for the ₹2,000 crore BIRAC–RDI Fund under India's ₹1 lakh crore Research, Development, and Innovation initiative, marking a major push to scale biotechnology innovations and strengthen India's position in the global biotech race.
A new Cochrane review analyzing 22 randomized clinical trials involving 1,995 adults found intermittent fasting produces no clinically meaningful weight loss compared to traditional dietary advice or no intervention.
Regeneron has consistently increased revenue over 35 years with blockbuster products like Dupixent and Eylea HD, while maintaining over a dozen phase 3 clinical trial candidates across multiple therapeutic areas.
New research demonstrates that physical activity after cancer diagnosis reduces mortality risk in less common cancers and enhances circadian clock function in tumor tissue, supporting exercise as a therapeutic intervention.
For the first time, 70% of cancer patients in the U.S. survive five years or more after diagnosis, according to the American Cancer Society's 2026 report. Advances in immunotherapy, CAR T-cell therapy, and screening technologies have driven significant improvements, particularly for lung cancer and myeloma. The definition of successful cancer care is evolving beyond survival to focus on quality of life and durable remissions.
Upstream Bio presented additional Phase 2 VIBRANT trial data showing verekitug reduced nasal polyp scores and congestion in chronic rhinosinusitis patients, while Phase 2 VALIANT trial results demonstrated significant reductions in asthma exacerbations with multiple dosing regimens.
Bristol Myers Squibb and SystImmune reported that antibody-drug conjugate izalontamab brengitecan achieved statistically significant improvements in both progression-free and overall survival versus chemotherapy in a Phase III trial for triple-negative breast cancer.
Anbio Biotechnology shares gained following an upgrade from a sell rating to hold. The company reported $0.04 earnings per share and $2.29 million in quarterly revenue.
A large long-term NIH-funded trial found that older adults who practiced visual speed training were 25% less likely to develop Alzheimer's disease or other dementias even 20 years later, marking the first randomized clinical trial to assess such long-term links.
Researchers at Adelaide University found that salcaprozate sodium (SNAC), used in oral semaglutide formulations, was associated with gut bacteria changes, elevated inflammatory markers, and reduced brain-derived protein levels in a 21-day animal study.
Teva and Sanofi reported durable 44-week efficacy for duvakitug in inflammatory bowel disease, while the FDA accepted Teva's application for TEV-749, a once-monthly olanzapine injection for schizophrenia.
Aardvark Therapeutics has voluntarily paused its Phase 3 HERO trial testing ARD-101 for hyperphagia in Prader-Willi Syndrome patients after reversible cardiac observations were identified during safety monitoring, delaying expected topline data beyond Q3 2026.
Three GLP-1 weight-loss drugs—semaglutide, tirzepatide and retatrutide—reduced weight and improved metabolic health in mice lacking the MC4R gene, offering potential treatment for rare genetic obesity.
Corcept Therapeutics received an FDA Complete Response Letter denying approval of relacorilant for hypertension secondary to hypercortisolism, triggering a 44.76% stock decline and multiple securities class actions.
Artificial intelligence is revolutionizing rare disease diagnosis, cutting diagnostic timelines from years to weeks. Rare Disease Day on February 28 highlights challenges faced by over 300 million people worldwide living with more than 7,000 distinct rare conditions.
