CHMP
EMA's CHMP Recommends Against Approval for Eisai, Biogen's Alzheimer's Drug Leqembi in Europe
The committee said the drug's modest clinical benefit doesn't outweigh its significant safety risks, but Eisai will ask the CHMP to reexamine its opinion.
CHMP Recommends AstraZeneca's Tagrisso, Chemo for Advanced EGFR-Mutated NSCLC
The committee recommended the combination after seeing that it reduced the risk of disease progression or death by 38 percent compared to just Tagrisso.
EMA's CHMP Issues Positive Opinion on Pfizer's Hemophilia B Gene Therapy
The gene therapy, which delivers a variant of the FIX gene, has already been approved in the US and Canada.
PTC Therapeutics' DMD Drug to Remain Available in Europe as CHMP Reviews Opinion
The European Commission has decided not to adopt the CHMP's negative opinion on the drug and has asked the committee to reevaluate its recommendation.
CHMP Recommends AstraZeneca's Truqap With Faslodex for Certain Breast Cancer Patients
In a Phase III trial, the Truqap-Faslodex combo reduced the risk of disease progression or death by 50 percent compared to Faslodex alone.