CHMP Nod to JNJ's Rybrevant Based on Data From PALOMA-3 Study The CHMP recommendation for the SC formulation of Rybrevant was based on positive data from the phase III PALOMA-3 study.

Positive CHMP opinions Meanwhile, the CHMP this week issued positive recommendations for several therapies, including Merck’s blockbuster-to-be Winrevair for pulmonary arterial hypertension (PAH).

The CHMP recommended the approval of Imfinzi in combination with gemcitabine and cisplatin as a neoadjuvant treatment for muscle-invasive bladder cancer (MIBC), followed by Imfinzi as monotherapy ...

ORION CORPORATION PRESS RELEASE 20 JUNE 2025 at 13.30 EEST. CHMP adopts positive opinion for the marketing authorisation of darolutamide in combination with androgen deprivation therapy for ...

Thumbs-up for J&J’s Carvykti The CHMP also has recommended (PDF) approval of Johnson & Johnson’s Carvykti (cilta-cel) for earlier treatment of relapsed and refractory multiple myeloma (RRMM).

CHMP Recommends the Approval of Dong-A ST’s IMULDOSA, a Biosimilar to Stelara® IMULDOSA obtained an approval recommendation from CHMP, who often sets the course of an EU marketing authorisation ...