Curated news and analysis on clinical trials, drug approvals, and medical research.
Savara Inc. announced the FDA has filed for review the BLA for MOLBREEVI to treat autoimmune PAP, granting Priority Review with a PDUFA action date of August 22, 2026. The therapy could become the first approved treatment for this rare lung disease.
New COMP006 phase 3 data shows single-dose COMP360 psilocybin achieved a 3.8-point MADRS reduction in treatment-resistant depression, with results comparable to esketamine pivotal trials and rapid onset of effect.
The FDA has accepted Teva and Medincell's New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine formulation for schizophrenia treatment that showed no need for post-injection monitoring in Phase 3 trials.
The FDA has accepted Teva and Medincell's New Drug Application for olanzapine extended-release injectable suspension (TEV-'749), a once-monthly subcutaneous treatment for schizophrenia in adults that showed no evidence for post-injection monitoring requirements.
The U.S. Food and Drug Administration has cleared FluoGuide's Investigational New Drug application for FG001, enabling the company to proceed with a Phase 2 registration trial in high-grade glioma patients with first enrollment expected in Q2 2026.
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.
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.
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.
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.
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.
Former Novartis executive John Tsai has been appointed global head of R&D at Daiichi Sankyo, replacing Ken Takeshita effective April 1. Tsai brings over 25 years of leadership experience in drug development.
