Immunologic Factor
Gilead Withdraws US Indication for Sacituzumab Govitecan in Metastatic Urothelial Cancer
Sacituzumab Govitecan, Trodelvy, Bladder Cancer, Urothelial Cancer, Gilead Sciences, FDA, Accelerated Approval Withdrawal
Merck’s KEYTRUDA Receives 30th European Approval for Gynecologic Cancers
KEYTRUDA, pembrolizumab, European Commission, gynecologic cancers, endometrial cancer, cervical cancer, cancer treatment, immunotherapy.
Astellas Secures FDA Approval for Vyloy, a First-in-Class Claudin-Targeted Therapy for Gastric Cancers
Astellas, Vyloy, FDA Approval, Claudin 18.2, Gastric Cancer, Gastroesophageal Junction Cancer, HER2-negative, Zolbetuximab
Fierce Pharma AsiaAstellas’ first-in-class FDA nod; Otsuka’s IgAN win; Samsung Bio’s $1.2B contract
United States Food and Drug Administration, IGA Glomerulonephritis, Sibeprenlimab, Contract agreement, Samsung, first
NICE Rejects Alzheimer’s Drug Kisunla Despite UK Regulatory Approval
NICE, Alzheimer’s disease, donanemab, Kisunla, Eli Lilly, MHRA, NHS, cost-effectiveness
Pfizer Secures FDA Approval to Expand RSV Vaccine Abrysvo for High-Risk Adults Aged 18-59
Pfizer, RSV vaccine, Abrysvo, FDA approval, high-risk adults, immunocompromised adults
Roche Abandons Tau Antibody Project, Returns Rights to UCB After $120M Investment
Roche, UCB, tau antibody, Alzheimer’s disease, bepranemab, $120M investment
Otsuka Seeks Accelerated Approval for Sibeprenlimab in IgA Nephropathy Following Positive Phase III Interim Results
Otsuka, sibeprenlimab, IgA nephropathy, Phase III trial, accelerated approval, FDA, kidney disease, autoimmune disease, APRIL antibody.
FDA Places Partial Clinical Hold on BioNTech’s Anti-CTLA-4 Antibody Trial
BioNTech, FDA, partial clinical hold, anti-CTLA-4 antibody, clinical trial, OncoC4
Novo Nordisk’s Alhemo Nears EU Approval: A Breakthrough in Haemophilia Treatment
Novo Nordisk, Alhemo, Haemophilia A and B, Inhibitors, European Medicines Agency (EMA), CHMP positive opinion, Subcutaneous prophylactic treatment, Concizumab