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 […]
March 22, 2024
Bringing more drug competition to the market is a top priority of the Administration, the Department of Health and Human Services (HHS), and FDA. In 2017, […]
March 22, 2024
The European Medicines Agency (EMA) has granted a marketing authorization to Novartis Europharm for Fabhalta (iptacopan) for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) who have […]
March 22, 2024
By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of […]
March 22, 2024
The Prescription Drug User Fee Act of 1992 (PDUFA), Biosimilar User Fee Act of 2012 (BsUFA), and Generic Drug User Fee Amendments of 2012 (GDUFA) authorize […]
March 22, 2024
TOPLINE: Anti-osteoporosis medications reduce fracture risk similarly, regardless of whether patients are younger or older than 70 years. METHODOLOGY: Investigators conducted the study as part of […]
March 22, 2024
TOPLINE: Despite best efforts, non-clinical practice staff do not appear to benefit from educational interventions aimed at improving the timeliness of shingles diagnosis (ie, within 72-144 […]
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