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Mesoblast Says Resumbits Biologic License Application To FDA For Remestemcel-L In Children With With Steroid-Refractory Acute Graft Versus Host Disease (Sr-aGVHD)

Validation of Remestemcel-L Potency Assay used in the Phase 3 Trial which Measures In-Vivo Activity based on Mechanism of Action Assay Identifies High-Potency Product Lots Associated with Enhanced Survival New Data Show that Remestemcel-L Improves Inflammatory Biomarkers and Survival in Children at Highest Risk of Mortality

MESO

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February PDUFA Catalysts Biotech Investors Must Know: Sanofi’s Bleeding Disorder Drug, Regeneron’s Twin Eylea Label Expansions, 3 Delayed Approvals And More

The year has started well for biopharma companies on the regulatory front, as most decisions handed out during January were positive. The Food and Drug Administration has already cleared four new molecular entities for the year.

APLS

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ChromaDex Shares Promising Findings From A Clinical Study Showcasing Combined Metabolic Activators, Featuring Nicotinamide Riboside, Improved Cognitive Functions In Alzheimer’s Disease Patients

This first-of-its-kind human clinical study in AD patients showcased CMA supplementation significantly improved cognitive function and associated biomarkers ChromaDex Corp. (NASDAQ:CDXC), a global bioscience company

CDXC

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FDA Has Granted Breakthrough Therapy Designation To Moderna’s Respiratory Syncytial Virus Vaccine Candidate, mRNA-1345

The designation is based on topline data from the ConquerRSV Phase 3 efficacy trial, which demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease.The designation is based on topline data from the ConquerRSV Phase 3 efficacy trial, which demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease.

MRNA

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Regeneron, Sanofi Announced Earlier , Dupixent Recommended For Expanded EU Approval By The CHMP To Treat Children As Young As Six Months Old With Severe Atopic Dermatitis

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent® (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy.

REGN