Pharmacologic Substance
Iterum Therapeutics Secures FDA Approval for Orlynvah, Breaking Two-Decade Drought in New UTI Treatments
Iterum Therapeutics, FDA Approval, Orlynvah, Uncomplicated Urinary Tract Infections (uUTIs), Sulopenem Etzadroxil and Probenecid, Oral Penem
GSK Invests $800 Million in Pennsylvania Site Expansion to Boost Vaccine and Medicine Production
GSK, Pennsylvania, manufacturing expansion, vaccine production, medicine manufacturing, $800 million investment
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
Tyra Biosciences Unveils Early Data for FGFR3 Inhibitor, TYRA-300, in Challenge to J&J’s Balversa
Tyra Biosciences, TYRA-300, Balversa, J&J, bladder cancer, urothelial carcinoma, FGFR3 inhibitor, safety concerns, efficacy data
Vabysmo’s Growth Pace Slows in Q3, Still on Track for Dominance in Eye Disease Market
Vabysmo, Roche, Regeneron, Eylea HD, eye disease market, vascular endothelial growth factor A (VEGF-A) therapy, age-related macular degeneration (AMD), diabetic macular edema (DME).
Alpha-9 Radios Secures $175M Funding for RLT Portfolio Advancement
Alpha-9 radios, $175M funding, RLT portfolio, radiopharmaceuticals, biotech investment
NICE Rejects Alzheimer’s Drug Kisunla Despite UK Regulatory Approval
NICE, Alzheimer’s disease, donanemab, Kisunla, Eli Lilly, MHRA, NHS, cost-effectiveness