tldrdaily.news logo
Tag

Medicines Approval

All articles tagged with #medicines approval

health3 months ago

CHMP Approves New Therapies for Immune Thrombocytopenia and Other Conditions

The EMA's CHMP recommended approval for two new medicines, Brinsupri for bronchiectasis and Wayrilz for immune thrombocytopenia, while advising against Rezurock for graft-versus-host disease. It also approved extensions for eight existing medicines, withdrew an application for hydrocortisone in preterm infants, confirmed the suspension of Oxbryta for sickle cell disease, and introduced a new administration route for Saphnelo. The meeting's agenda and minutes are forthcoming.

via European Medicines Agency|
#brinsupri#ema#health
health5 months ago

European Regulators Show Mixed Support for Lilly’s Alzheimer’s Treatments

The EMA's CHMP recommended approval for 13 new medicines in July 2025, including treatments for rare diseases, cancer, HIV prevention, and postpartum depression, along with biosimilars, generics, and updates on vaccine compositions. Several applications were withdrawn or received negative opinions, while some medicines underwent re-examination or extension of indications. The meeting also included safety reviews and updates on ongoing public health procedures.

via European Medicines Agency|
#2025#chmp#ema
medicinehealthcare2 years ago

"Key Takeaways from CHMP's October 2023 Meeting | European Medicines Agency"

The European Medicines Agency's Committee for Medicinal Products Human Use (CHMP) recommended seven new medicines for approval, including treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, and hyperargininemia. The committee also granted extensions of therapeutic indications for eight medicines and initiated a review of the benefits and risks of a medicine used to treat primary biliary cholangitis.

via European Medicines Agency ||
#duchenne-muscular-dystrophy#european-medicines-agency#medicinehealthcare