The European Commission approved Pfizer's respiratory syncytial virus vaccine for the prevention of lower respiratory tract ...

Sarepta Therapeutics (SRPT) stock drops as the EU officials request a clinical hold on trials involving its gene therapy ...

Eli Lilly's Alzheimer's treatment is approved for use in the U.S. but the European Medicines Agency recommended against the ...

Eli Lilly's Kisunla was approved in the U.S. for Alzheimer's last year, but now advisers to the European Medicines Agency say ...

A key result of a workshop series of European regulatory authorities and HTA agencies: Drug studies should be designed in such a way that they address both regulatory questions and the essential ...

CHMP recommends approval for XOANACYL, an oral therapy for use in the following therapeutic areas: Iron deficiency, chronic renal failure and ...

The EMA has recommended refusing marketing authorization for donanemab, a monoclonal antibody against amyloid beta, in the ...

After failing to pass muster with England’s drug reimbursement watchdog earlier this month, Eli Lilly’s Alzheimer’s disease ...

The European Medicines Agency will review GSK's request to approve its asthma drug Nucala as an additional treatment for ...

A European regulatory committee has rejected Eli Lilly’s U.S.-approved Alzheimer’s disease treatment over potentially ...