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

Averoa, a biopharmaceutical company bringing innovative therapeutic solutions to people with renal diseases, today announces a positive opinion from the European Medicines Agency (EMA)’s Committee for ...

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

Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) today provided an update on the ongoing regulatory review of the Marketing ...

Eli Lilly, which is seeking European approval of Kisunla for the treatment of early symptomatic Alzheimer's, said it will seek re-examination by CHMP. The Indianapolis drugmaker said it remains ...

PTC Therapeutics' Translarna loses EU conditional approval, but countries may allow continued use. PTC submitted four FDA ...

Krystal Biotech's VYJUVEK, a first-mover gene therapy for DEB, has received a positive CHMP recommendation. Read why KRYS ...

BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced that the Committee for Medicinal Products for ...

The regulatory agency's positive opinion is based on positive results from the Phase 3 CheckMate -67T trial. Following this recent announcement, the CHMP opinion will now be reviewed by the ...

A key European regulatory committee has recommended against ... said it will seek re-examination by CHMP. The Indianapolis drugmaker said it remains confident in the safety and effectiveness ...

“Today's positive CHMP opinion marks another important step ... “TEVIMBRA is the cornerstone of our solid tumor portfolio with 58 regulatory approvals in 18 months and is being studied in ...