Browsing Tag
Committee for Medicinal Products for Human Use
11 posts
Amgen data breach: Patient records exposed via third-party cloud storage
Amgen said patient health data was exfiltrated via third-party cloud storage in an incident deemed material days before its August 4 Q2 earnings release.
What the CHMP’s positive view on lomitapide reveals about the evolving HoFH treatment landscape in children
See how Chiesi Group’s paediatric lomitapide expansion could reshape HoFH treatment access, payer dynamics, and rare disease growth across Europe.
How FIREFLY1 data positioned Ojemda for conditional EU approval in pediatric glioma
How FIREFLY1 data positioned Ipsen’s Ojemda for conditional EU approval in pediatric glioma and what it means for investors and competitors.
Bracco Imaging gains regulatory momentum as CHMP supports gadopiclenol for patients under two
Find out how Bracco Imaging S.p.A.’s Vueway gadopiclenol won CHMP backing for infants under two and what it means for pediatric MRI safety in Europe.
FDA approves Pfizer’s HYMPAVZI for breakthrough hemophilia treatment
In a major leap for hemophilia patients, Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug…
Advancing bladder cancer treatment: EMA scrutinizes Astellas-Pfizer’s innovative therapy
A groundbreaking development in bladder cancer treatment is on the horizon as Astellas Pharma Inc. and Pfizer Inc.…
CHMP recommends approval for BeiGene’s tislelizumab in ESCC treatment
BeiGene, a global biotechnology firm, has revealed that the European Medicines Agency’s (EMA) Committee for Medicinal Products for…
CHMP endorses Merck’s gefapixant for EU approval for chronic cough treatment
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for gefapixant,…
Menarini’s ORSERDU gets CHMP positive opinion in advanced breast cancer
The Menarini Group and its subsidiary, Stemline Therapeutics Inc., have received a favorable opinion from the European Medicines…
CHMP adopts positive opinion for avapritinib for PDGFRA D842V mutant GIST
US precision therapy company Blueprint Medicines said that the Committee for Medicinal Products for Human Use (CHMP) of…