(IN BRIEF) GSK has announced that China’s National Medical Products Administration has accepted for review a New Drug Application for bepirovirsen, an investigational antisense oligonucleotide designed to treat adults with chronic hepatitis B. The submission is supported by Phase III … Read the full press release →
Posted in Healthcare, Marketing, Pharma & Biotech, Science, United Kingdom
Tagged antisense oligonucleotide, ASO therapy, B-Well 1 trial, B-Well 2 trial, Bepirovirsen, breakthrough therapy designation, CHB, China healthcare, chronic hepatitis B, clinical trials, drug development, functional cure, GSK Moves Closer to Transforming Chronic Hepatitis B Care with Bepirovirsen NDA Review in China, GSK plc, GSK Strengthens Infectious Disease Portfolio with Regulatory Submission for Novel Hepatitis B Therapy in China, HBsAg, hepatitis B surface antigen, infectious disease, liver cancer, National Medical Products Administration, NMPA, viral infection
(IN BRIEF) GSK plc has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) targeting chronic hepatitis B (CHB). The Fast Track designation aims to expedite the development … Read the full press release →
Posted in Business, Education, Financial, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged Bepirovirsen, Chronic Hepatitis B Treatment, FDA Fast Track, GSK
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