May 15, 2024
FDA Rejects Hepatitis B Vaccine Update Due to Inadequate Documentation and Data
FDA, hepatitis B vaccine, vaccine update, document destruction, insufficient data, rejection
WHO Negotiations Extended for Global Pandemic Agreement
World Health Organization (WHO), pandemic accord, international agreement, global health, deadline, negotiations, public health emergency, disease outbreaks.
Extended FDA Review Timeline for Ascendis’ Hormone Therapy
Ascendis Pharma, hormone therapy, FDA review, delay, 3 months extension.
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
BioMarin Downsizes Workforce Amidst Strategic R&D Shift
BioMarin, job cuts, R&D refocus, biotechnology, strategic shift, workforce reduction
Blackstone Invests $300M in Uniquity Bio to Unleash Merck Drug’s Inflammation & Immunology Potential
Blackstone, Uniquity Bio, Merck, Inflammation & Immunology, Investment, Drug Development, Biotechnology
Pioneering Regulatory Compliance in Laboratory Markets: A Strategic Approach
Regulated Labs, Market Strategy, Compliance, Innovation, Leadership
FDA Imposes Three-Month Delay on Ascendis’ Hypoparathyroidism Treatment
Ascendis Pharma, hypoparathyroidism, FDA, drug approval, delay, three-month setback, regulatory hurdle, treatment, endocrine disorder.
Revolutionizing Pharmaceuticals: Nabla Bio Secures $26M for AI-Powered Protein Design
Nabla Bio, generative AI, protein design, funding, pharmaceutical partners, biotechnology, drug discovery.
FDA Rejects Dynavax’s Heplisav-B Expansion Due to Data Gaps
FDA, Dynavax, Heplisav-B, data gaps, rejection, expansion, vaccine, hepatitis B