CHMP
Krystal Biotech Expects CHMP Opinion on Skin Condition Gene Therapy in Early 2025
The firm is on track to launch the gene therapy for dystrophic epidermolysis bullosa, called Vyjuvek in the US, in Germany in Q2 2025.
AstraZeneca's Tagrisso Gets Nod From EMA's CHMP in Unresectable EGFR-Mutated NSCLC
If approved by the EC, Tagrisso will be the first targeted therapy for European patients with unresectable EGFR-mutated cancer.
CHMP Recommends BMS's Augtyro for ROS1-Positive NSCLC, NTRK-Positive Tumors
The European Commission will decide whether to approve Augtyro in these two indications in January 2025.
EMA's CHMP Now Recommends Approval for Eisai, Biogen's Alzheimer's Drug Leqembi in Europe
The agency had previously recommended against marketing authorization for the Alzheimer's drug but reconsidered after a review.
CHMP Recommends BeiGene's Tevimbra for First-Line PD-L1-Positive Gastric, Esophageal Cancers
The recommendation was based on results from two Phase III trials showing that Tevimbra plus chemo improved overall survival over chemo alone.