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 ...

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 ...