Curated news and analysis on clinical trials, drug approvals, and medical research.
Abivax announced novel preclinical and clinical data for obefazimod at ECCO 2026, highlighting anti-fibrotic potential in Crohn's disease, favorable safety profile, and rapid onset of symptomatic relief in inflammatory bowel disease patients.
U.S. military strikes alleged drug trafficking boat in Eastern Pacific, killing three people. The attack brings total deaths from Trump administration boat strikes to 148 since September.
Dr. Reddy's Laboratories secures FDA acceptance for DRL-AB, the first abatacept biosimilar application in the U.S., targeting a market worth $3.7 billion annually and positioning the company for first-mover advantage.
The US FDA has accepted Dr Reddy's Biologics License Application for DRL-AB, a proposed interchangeable biosimilar to Orencia (abatacept) for intravenous infusion, marking the first abatacept biosimilar submission.
Researchers at DZNE and the University of Tübingen have identified neurofilament light chain (NfL) as a blood biomarker detectable across animal species, with levels increasing with age and predicting lifespan in mice.
Prothena reported Q4 2025 adjusted loss of 45 cents per share, meeting estimates, while ending the year with $308.4 million in cash. Roche and Novo Nordisk advanced partnered programs prasinezumab and coramitug into Phase III trials.
Vanda Pharmaceuticals announced FDA approval for BYSANTI tablets to treat Bipolar I manic episodes and schizophrenia in adults. The drug has patent protection extending to 2044 and will be commercially available in Q3 2026.
The FDA has accepted Teva Pharmaceuticals' New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine injection for treating schizophrenia in adults, based on Phase 3 trial data showing efficacy consistent with existing formulations without requiring post-injection monitoring.
The controversy over direct-to-consumer prescription drug advertising has gained renewed attention from the Trump administration and legislators, with spending reaching $9 billion in 2024 and debate centering on whether such ads benefit or harm consumers.
The FDA has approved BYSANTI (milsaperidone), a new chemical entity for treating bipolar I disorder and schizophrenia in adults. The drug is Vanda's second approval in less than two months and is expected to launch in Q3 2026.
The U.S. Food and Drug Administration has approved Vanda Pharmaceuticals' Bysanti for treating schizophrenia and acute bipolar I disorder. The company expects to launch the drug in the third quarter of 2026.
The FDA has accepted Dr. Reddy's Laboratories' BLA for DRL_AB, a proposed interchangeable biosimilar to abatacept, submitted in December 2025. The application is the first for an abatacept biosimilar and is supported by Phase 1 data showing pharmacokinetic similarity.
The FDA has approved a once-monthly dosing schedule for subcutaneous amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) combined with lazertinib for first-line treatment of EGFR-mutated advanced NSCLC, based on PALOMA-2 trial data showing comparable efficacy to biweekly dosing.
Savara Inc. announced the FDA has accepted its Biologics License Application for Molbreevi to treat autoimmune pulmonary alveolar proteinosis, granting Priority Review with a PDUFA action date of August 22, 2026.
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.
ImmunityBio receives conditional EU marketing authorization for Anktiva combination therapy in bladder cancer, covering 33 countries, while establishing distribution partnerships in Saudi Arabia for bladder and lung cancer patients.
