Qualitative Concept
FDA Approves Protega’s 10 mg Abuse-Deterrent Opioid Roxybond for Pain Management
FDA approval, Protega Pharmaceuticals, Roxybond, abuse-deterrent opioid, pain management, SentryBond technology
FDA Approves Iterum’s Orlynvah for Uncomplicated UTIs, Offering New Hope for Patients with Limited Treatment Options
Iterum Therapeutics, Orlynvah, FDA approval, uncomplicated urinary tract infections (uUTIs), oral antibiotic, sulopenem, antimicrobial resistance
Mitigating Risks in mRNA Manufacturing: Strategies for Smooth Transition from Preclinical to Clinical Stages
mRNA manufacturing, risk management, preclinical to clinical transition, quality control, regulatory compliance, raw material selection, process automation, analytical methods.
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
Gilead Withdraws US Indication for Sacituzumab Govitecan in Metastatic Urothelial Cancer
Sacituzumab Govitecan, Trodelvy, Bladder Cancer, Urothelial Cancer, Gilead Sciences, FDA, Accelerated Approval Withdrawal
Medtronic’s Affera System: A Breakthrough in Electrophysiology with FDA Approval for All-in-One Pulsed Field Ablation
Medtronic, Affera, FDA approval, pulsed field ablation, electrophysiology, atrial fibrillation, cardiac ablation
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
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