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FDA Rejects Hepatitis B Vaccine Update Due to Inadequate Documentation and Data
FDA, hepatitis B vaccine, vaccine update, document destruction, insufficient data, rejection
Extended FDA Review Timeline for Ascendis’ Hormone Therapy
Ascendis Pharma, hormone therapy, FDA review, delay, 3 months extension.
Blackstone Invests $300M in Uniquity Bio to Unleash Merck Drug’s Inflammation & Immunology Potential
Blackstone, Uniquity Bio, Merck, Inflammation & Immunology, Investment, Drug Development, Biotechnology
BioMarin Downsizes Workforce Amidst Strategic R&D Shift
BioMarin, job cuts, R&D refocus, biotechnology, strategic shift, workforce reduction
Eisai and Biogen Overcome Filing Hitch, Initiate FDA Submission for Subcutaneous Leqembi
Eisai, Biogen, FDA submission, Leqembi, subcutaneous, Alzheimer’s disease, rolling submission, BLA, clinical trials, monoclonal antibody, amyloid beta, neurodegenerative disorder
FDA Imposes Three-Month Delay on Ascendis’ Hypoparathyroidism Treatment
Ascendis Pharma, hypoparathyroidism, FDA, drug approval, delay, three-month setback, regulatory hurdle, treatment, endocrine disorder.
Pioneering Regulatory Compliance in Laboratory Markets: A Strategic Approach
Regulated Labs, Market Strategy, Compliance, Innovation, Leadership
Sands Capital Successfully Raises $555 Million for Third Life Sciences Venture Fund
Sands Capital, life sciences, venture fund, fundraising, healthcare investments, biotechnology, medical technology, pharmaceuticals, healthcare innovation.
Beyond Weight Loss: Wegovy’s Cardiovascular Benefits Uncovered in New Study
Wegovy, cardiovascular benefits, weight loss, GLP-1 receptor agonist, heart health, obesity treatment, diabetes management, clinical study.
FDA Rejects Dynavax’s Heplisav-B Expansion Due to Data Gaps
FDA, Dynavax, Heplisav-B, data gaps, rejection, expansion, vaccine, hepatitis B