September 16, 2024
FDA Advisory Committee Votes Against Ocaliva for Primary Biliary Cholangitis Due to Safety Concerns
Ocaliva, FDA, Primary Biliary Cholangitis, Liver Disease, Safety Concerns, Advisory Committee Vote
Streamlining Drug Development: The Power of Phase-Appropriate Technology Transfers
Technology Transfer, Phase-Appropriate Technology Transfer, Drug Development, Pharmaceutical Manufacturing, CDMOs (Contract Development and Manufacturing Organizations), Regulatory Compliance, Innovation in Drug Development
iTeos-GSK’s TIGIT Combination Demonstrates Superior Tumor Shrinkage in Phase 2 Trial
iTeos Therapeutics, GSK, TIGIT, EOS-448, Jemperli, Phase 2 trial, tumor shrinkage, immuno-oncology, cancer treatment
FDA Approves Ebglyss (Lebrikizumab-lbkz) for Moderate-to-Severe Atopic Dermatitis in Adults and Children 12 Years and Older
Ebglyss, Lebrikizumab-lbkz, FDA Approval, Moderate-to-Severe Atopic Dermatitis, Eczema Treatment
AstraZeneca’s Imfinzi Demonstrates Significant Survival Benefits in Muscle-Invasive Bladder Cancer
AstraZeneca, Imfinzi (durvalumab), Muscle-Invasive Bladder Cancer (MIBC), Perioperative Treatment, Event-Free Survival (EFS), Overall Survival (OS), NIAGARA Phase III Trial
FDA Approves Ocrevus Zunovo: A Breakthrough Subcutaneous Injection for Multiple Sclerosis
Ocrevus Zunovo, FDA Approval, Subcutaneous Injection, Multiple Sclerosis, Relapsing Multiple Sclerosis (RMS), Primary Progressive Multiple Sclerosis (PPMS), Halozyme Therapeutics, ENHANZE drug delivery technology.
Nuvation Bio Advances with Pooled Data for ROS1-positive Lung Cancer Treatment, Eyes FDA Submission
Nuvation Bio, ROS1-positive NSCLC, taletrectinib, TRUST-I, TRUST-II, FDA submission, lung cancer treatment
Biotech IPO Market Sees Rare Upsurge with Triple Listing Success
Biotech IPO, Market Flux, Tripleheader, Bicara Therapeutics, Zenas BioPharma, MBX Biosciences, Stock Surge, Pharmaceutical Industry
Roche Secures FDA Approval for Subcutaneous Ocrevus and Tecentriq, Lilly Gains Approval for Eczema Treatment
FDA approvals, Roche, Subcutaneous products, Ocrevus, Tecentriq, Lilly, Eczema treatment, Pharmaceutical industry, Biopharma news
ESMO 2023: Merck’s Welireg Demonstrates Sustained PFS Benefit in Advanced Renal Cell Carcinoma, Despite Ongoing OS Concerns
Merck & Co., Welireg (belzutifan), ESMO 2023, Advanced Renal Cell Carcinoma (RCC), Progression-Free Survival (PFS), Overall Survival (OS), LITESPARK-005 trial