EMA/CHMP June 2024 meeting highlights

28 June 2024

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended seven novel medicines and one biosimilar for approval at its June 2024 meeting.

The committee recommended granting a marketing authorization for Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Cilag’s Balversa(erdafitinib), for the treatment of adult patients with unresectable or metastatic urothelial carcinoma, a cancer of the bladder and urinary system.

The CHMP adopted a positive opinion for Eurneffy (epinephrine), from ARS Pharmaceuticals (Nasdaq: SPRY), the first emergency treatment against allergic reactions that is administered as a nasal spray, not as an injection. The CHMP recommended additional risk minimization measures to reduce and prevent the potential risk of an inappropriate use of the device.

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