The European panel has expanded delivery options for multiple myeloma by approving a subcutaneous (SC) option for a key anti‑CD38 myeloma therapy. At its March 2026 […]
A new oral PI3K delta inhibitor for a rare primary immunodeficiency has moved a step closer to EU approval. The European Medicines Agency’s (EMA’s) Committee for […]
The FDA has approved the first once-weekly basal analog insulin, Novo Nordisk’s icodec-abae (Awiqli injection 700 units/mL), for adults with type 2 diabetes (T2D). The product […]
Patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer in Europe may soon have a new bladder-sparing treatment option after the European Medicines Agency’s Committee for […]
The European Medicines Agency (EMA) has recommended granting pediatric use marketing authorization (PUMA) for Bopediat (furosemide, Proveca Pharma Limited) to treat children younger than 18 years […]
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two drugs for the treatment of adults with small […]
The FDA has granted accelerated approval to the gene therapy marnetegragene autotemcel (Kresladi, Rocket Pharmaceuticals) for the treatment of pediatric patients with severe leukocyte adhesion deficiency […]
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Tecovirimat SIGA should no longer be used for the treatment of […]
The FDA has approved relacorilant (Lifyorli, Corcept Therapeutics) in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have […]
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