EMA
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.
Anocca Seeking EMA Permission to Test TCR T-Cell Therapy in KRAS-Mutated Pancreatic Cancer
The Swedish firm plans to expand the VIDAR-1 umbrella trial to study additional KRAS-targeting product candidates in the future.
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.