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Biocon Secures Health Canada Nod for Micafungin Injection
Biocon Pharma receives Health Canada approval for Micafungin for Injection (50 mg, 100 mg), strengthening its biosimilars and generics portfolio.
Bayer Reports Positive Phase 3 Results for Investigational Cardiac Amyloidosis Imaging Agent
REVEAL study demonstrates strong diagnostic sensitivity and specificity of I 124 evuzamitide PET/CT radiotracer for detecting cardiac amyloidosis, supporting plans for regulatory discussions with the FDA.
P&G Health Launches Neurobion Nerve Pain Relief Cream for Targeted Symptomatic Relief
P&G Health introduces a specialised topical cream with capsaicin and soothing ingredients to help manage nerve-related pain, tingling and burning sensations in hands and feet.<br />
US FDA Upgrades AI Systems, Launches HALO Data Platform to Modernise Regulatory Operations
FDA unveils Elsa 4.0 AI upgrade and consolidates over 40 data systems into the new HALO platform to streamline workflows, enhance regulatory science and accelerate treatment approvals.
Samsung Bioepis achieves positive Phase 1 results for Keytruda biosimilar candidate SB27
The biopharmaceutical company announced that its proposed pembrolizumab biosimilar, SB27, met primary pharmacokinetic endpoints in a global Phase 1 study involving non-small cell lung cancer patients, advancing its oncology biosimilar pipeline.
Chance Pharma Secures NMPA Acceptance for CXG87 Respiratory Drug NDA
Chance Pharma secures National Medical Products Administration acceptance of NDA for CXG87, marking its first filing and a key step toward commercialisation of a novel respiratory therapy.
Pierre Fabre Pharmaceuticals Reports FDA Update on Tabelecleucel BLA
Pierre Fabre Pharmaceuticals aligns with US Food and Drug Administration (FDA) on BLA resubmission path for tabelecleucel, an allogeneic T-cell therapy for Epstein-Barr virus positive post-transplant lymphoproliferative disease.
Merck Becomes Sole Testing Provider for FDA-Approved Gene Therapies of Genetix Biotherapeutics
Merck signs a 5-year deal as sole testing provider for Genetix Biotherapeutics’ gene therapies, delivering end-to-end testing to support safe, reliable commercialisation of advanced therapies.
China's CDE Grants Priority Review to Bayer's FXIa Inhibitor
China’s Center for Drug Evaluation (CDE) grants Priority Review (PR) to Bayer’s FXIa inhibitor, highlighting its potential clinical value in reducing stroke risk.
US FDA Launches One-Day Inspections to Boost Oversight
The FDA launches one-day inspectional assessments to strengthen oversight, using shorter, targeted reviews to complement standard inspections.
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