The US Food and Drug Administration has approved afamitresgene autoleucel (afami-cel) (Tecelra, Adaptimmune LLC) to treat advanced synovial sarcoma. Afami-cel — the first engineered cell therapy […]

The US Food and Drug Administration (FDA) has expanded the approval of dostarlimab-gxly (Jemperli, GSK) in conjunction with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for […]

The US Food and Drug Administration (FDA) has approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Research and Development, LLC) in combination with bortezomib, lenalidomide, and dexamethasone […]

AstraZeneca was taken to task last week by the US Food and Drug Administration’s (FDA’s) Oncology Drug Advisory Committee (ODAC) for failing to heed an agency […]

Patients are overdosing on compounded semaglutide due to errors in measuring and self-administering the drug and due to clinicians miscalculating doses that may differ from US […]

The European Medicines Agency (EMA) has recommended strengthening existing advice to minimize the risks from interactions between Mysimba (naltrexone/bupropion; Orexigen Therapeutics Ireland Limited) and opioid-containing medicines. […]

A drug to treat severe itching in patients with Alagille syndrome should be granted a marketing authorization in the European Union under what the European Medicines […]

Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended the granting of marketing authorization for Anzupgo (delgocitinib; LEO Pharma) to treat moderate to severe chronic […]

The US Food and Drug Administration (FDA) has approved the oral Janus kinase (JAK) inhibitor deuruxolitinib for the treatment of adults with severe alopecia areata. The […]