Browsing Tag
CHMP
19 posts
Lilly’s Olumiant moves closer to European approval for teen alopecia patients as CHMP issues positive opinion
Eli Lilly's Olumiant wins CHMP backing for adolescent alopecia areata with 42% response rates — EU approval imminent, U.S. decision due late 2026. Read the full analysis.
KEYNOTE-B96 final analysis: Merck’s Keytruda cuts death risk by 18% in recurrent ovarian cancer across all-comer population
Merck's Keytruda cuts death risk 18% in platinum-resistant ovarian cancer regardless of PD-L1 status. FDA approved, EU opinion positive. Read the full analysis.
Johnson & Johnson’s AKEEGA clears major EU hurdle with CHMP nod for mHSPC BRCA mutation indication
Johnson & Johnson’s EU backing for AKEEGA’s expanded prostate cancer label could reshape its oncology strategy and precision medicine footprint in 2026.
Positive CHMP opinion sets stage for GSK’s ready-to-use Shingrix syringe approval in Europe
GSK receives CHMP green light for Shingrix prefilled syringe. Learn how this vaccine format could simplify shingles protection across Europe.
IntraBio’s AQNEURSA earns positive CHMP opinion, bringing Niemann-Pick disease type C therapy closer to EU approval
IntraBio’s AQNEURSA earns positive CHMP opinion for Niemann-Pick disease type C, moving closer to EU approval after strong Phase III data and U.S. FDA nod.
Will CABOMETYX secure EU approval for advanced neuroendocrine tumors after CHMP’s positive opinion?
Ipsen’s CABOMETYX receives EMA's CHMP backing for advanced neuroendocrine tumors; EU approval expected in 2025 following FDA nod.
CHMP backs Lecanemab again for early Alzheimer’s as EC reviews approval
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion on…
Janssen’s subcutaneous amivantamab gains CHMP backing for EGFR-mutated lung cancer
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a…
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…
Dr. Reddy’s Laboratories secures key European endorsement for Rituximab biosimilar
In a significant development for the pharmaceutical industry, Dr. Reddy’s Laboratories Ltd. has received a positive opinion from…