Curated news and analysis on clinical trials, drug approvals, and medical research.
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.
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.
