Curated news and analysis on clinical trials, drug approvals, and medical research.
The MHRA has raised new safety concerns about the PATHWAYS clinical trial investigating puberty blockers in young people with gender incongruence, pausing preliminary work until issues are resolved with sponsor King's College London.
West Virginia University Cancer Institute has dosed the first patient in a phase 1/2 trial evaluating subcutaneous blinatumomab for CD19-positive mixed-phenotype acute leukemia, a rare disease with no FDA-approved therapies. The first patient achieved complete remission after one cycle.
Dr. Reddy's Laboratories has received FDA acceptance for its biosimilar application targeting Bristol-Myers Squibb's Orencia, marking the first U.S. application for an off-patent version of the arthritis treatment that generated $2.7 billion in 2025.
New research reveals semaglutide may directly repair cartilage in osteoarthritis patients, while a separate study raises concerns about SNAC, an ingredient used in oral semaglutide formulations, and its effects on gut health.
FDA Commissioner Marty Makary identified hospital contracting, IRB processes, and IND application timelines as key bottlenecks slowing US early-phase trials. China now conducts more clinical trials than the US and accounts for nearly a third of new global drug approvals.
The European Commission granted conditional marketing authorization for ImmunityBio's Anktiva for bladder cancer treatment across 27 EU countries. The company partnered with Accord Healthcare to deploy an 85-person sales force across 30 European countries.
Phase 2 trial data show lisocabtagene maraleucel achieved a 95% overall response rate in patients with relapsed or refractory marginal zone lymphoma, with a manageable safety profile and no new safety signals.
Switzerland-based CRISPR Therapeutics stands to benefit from increased Casgevy sales following partner Vertex Pharmaceuticals' fourth-quarter results, with five additional gene-editing therapies in clinical trials targeting larger patient populations.
The European Commission has approved a new 7.2 mg once-weekly maintenance dose of Wegovy (semaglutide injection) for adults with obesity, providing physicians with an additional treatment option for patients requiring further weight reduction after the 2.4 mg dose.
PDS Biotechnology adopted an amended protocol for its Phase 3 VERSATILE-003 trial, adding progression-free survival as an interim primary endpoint to support potential accelerated approval of PDS0101 in HPV16-positive head and neck cancer.
Tirzepatide, the active ingredient in Mounjaro, reduced alcohol intake by more than half in animal models and prevented relapse-like drinking behaviors, offering potential insights for alcohol use disorder treatment.
Researchers discovered that red blood cells act as "glucose sponges" in low-oxygen conditions, dramatically lowering blood sugar levels. A new drug called HypoxyStat completely reversed high blood sugar in diabetic mice, working better than existing medications.
Vir Biotechnology is set to report Q4 2025 earnings on Feb 23, 2026, with analysts expecting revenue of $19.91-$23.18 million and a loss of $0.41-$0.50 per share, marking a 61% year-over-year revenue increase.
Barclays initiated coverage on Merck with an overweight rating and $140 price target, citing expected product launches including enlicitide and pivotal trial readouts for tulisokibart in 2026.
The clinical trials industry is expected to grow from $61.93 billion in 2025 to $99.25 billion by 2033 at a 6.07% CAGR, driven by demand for innovative therapies and chronic disease prevalence. Clinical trials management systems are projected to reach $9.0 billion by 2035.
FDA approves AstraZeneca's Calquence plus venetoclax as first all-oral, 14-month fixed-duration regimen for first-line chronic lymphocytic leukemia, with 77% of patients progression-free at three years in Phase III trial.
GV Research Platform announced a strategic distribution partnership with Yurogen Biosystems to provide Indian biotechnology and pharmaceutical companies access to advanced antibody discovery capabilities for early-stage drug discovery and translational research.
Vanda Pharmaceuticals received FDA approval for Bysanti (milsaperidone), an atypical antipsychotic for schizophrenia and manic or mixed episodes in bipolar I disorder. The drug will be available by the third quarter of 2026.
Novo Nordisk's next-generation obesity drug CagriSema achieved 23% weight reduction compared to 25.5% for Eli Lilly's tirzepatide in an 84-week trial, sending Novo shares down 15% and erasing over $400 billion in market value since 2024.
The FDA has approved the combination of acalabrutinib and venetoclax as the first all-oral, fixed-duration BTK inhibitor-based regimen for previously untreated adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
