FDA completes inspection at Biocon Biologics' facility in Bengaluru
The U.S. FDA issued a Form 483 with five observations
The U.S. FDA issued a Form 483 with five observations
Replicate will receive research funding and could potentially receive up to approximately US$550 million
Accro will retain global rights to develop, manufacture, and commercialize AC-201 (excluding Chinese Mainland, Hong Kong SAR, and Macau SAR)
As with any medicine, the MHRA will keep the safety of gepotidacin under close review
Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission
Anthony brings more than 25 years of pharmaceutical development and CRO experience to his expanded role
Astaxanthin is a powerful antioxidant and red-orange carotenoid pigment found in various aquatic organisms
Vivo Bio Tech will have end-to-end responsibility for conducting the full spectrum of pre-clinical safety and regulatory studies
The randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants
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