March 22, 2024
This month, the European Medicines Agency (EMA) gave marketing authorization to bevacizumab-vikg (Lytenava, Outlook Therapeutics) for the treatment of neovascular (wet) age-related macular degeneration (AMD). The […]
March 22, 2024
Antimicrobial Regulatory Science Research Antimicrobial drug resistance is a major threat to public health. In March 2015, The National Action Plan for Combating Antibiotic-resistant Bacteria was […]
March 22, 2024
The European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of Emblaveo (aztreonam-avibactam), recommended for treating complicated intra-abdominal and urinary tract infections, […]
March 22, 2024
Recognized Interpretive Criteria FDA Identified Interpretive Criteria Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S SDDa I R S SDDa I R Enterobacteralesb ≤8/4 – […]
March 22, 2024
FDA has completed their review of the rationale document titled, “Piperacillin-Tazobactam Breakpoints for Pseudomonas aeruginosa” (MR15, January 2024), submitted by the Clinical and Laboratory Standards Institute […]
March 22, 2024
Recognized Interpretive Criteria Exceptions to the recognized standard of CLSI M100 Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacterales […]
March 22, 2024
The US Food and Drug Administration (FDA) has approved givinostat (Duvyzat) for treatment of Duchenne muscular dystrophy (DMD) in patients aged 6 years or older. Givinostat, […]
March 22, 2024
Controlled correspondence is a correspondence submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element […]
March 22, 2024
Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]