USA – FDA issues new standards for DTC prescription drug ads
The US Food and Drug Administration (FDA) published its final rule changing how companies must present the “major statement” in direct-to-consumer (DTC) TV and...
USA – FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy
Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic...
USA – FDA offers insight into product quality assessment principles
The US Food and Drug Administration (FDA) has issued draft guidance outlining its benefit-risk principles when evaluating product quality assessments for new drug applications...
USA – FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain...
FDA approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva...
USA – FDA expands KASA review program to drug substances
The US Food and Drug Administration (FDA) is now piloting its Knowledge-aided Assessment and Structured Application (KASA) drug review program for drug substances as...
USA – Pharma wants FDA’s IND reporting rule better aligned with ICH E2F
Pharmaceutical industry stakeholders urged the US Food and Drug Administration (FDA) to better align its investigational new drug application (IND) annual reporting proposal with...
USA – FDA offers first guidance on stimulant use disorder drug development
The US Food and Drug Administration (FDA) has published a draft guidance that for the first time offers recommendations for drug development and clinical...
USA – FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder
Today, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme...
USA – FDA’s drug quality report card details enforcement trends, increased inspections in 2022
In its latest State of Pharmaceutical Quality report, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) cited an increase in...
USA – FDA withdraws pre-term birth drug Makena
Two-and-a-half years after it first proposed doing so, the US Food and Drug Administration (FDA) has made a final decision to immediately withdraw Makena...
