PDUFA, the Prescription Drug User Fee Act of 1992, mandates the FDA to charge firms for drug and biologic application reviews. Revenue supports faster safety and efficacy assessments.
Genascence Corporation has launched a Phase 1b clinical study to evaluate the efficacy of their gene treatment, codenamed GNSC-001, targeting knee osteoarthritis.
H1 receptor antagonists are drugs that block histamine action, relieving allergic reactions. The future holds potential for advancements in treating allergic and inflammatory disorders.
In biology, a specific region typically refers to a specific area within a biological context, such as a particular area on a gene, chromosome, protein, or cell.
"Sustained-release preparations" are formulations designed for prolonged drug release to maintain enduring effectiveness, often through a first-order release rate.
Alvotech, a global biopharma company specializing in biosimilars, reported positive early results from a key trial of AVT06, its candidate similar to Eylea® (aflibercept).
OBI Pharma announced the FDA has approved its investigational new drug application for OBI-992, allowing the start of a phase 1/2 clinical trial to evaluate their novel TROP2-targeted antibody-drug conjugate for cancer treatment.
Belief BioMed Group announced the start of patient treatment in a major BBM-H803 study. This gene therapy aims to treat hemophilia A and is independently developed by Belief BioMed.