News

Donanemab receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in early symptomatic Alzheimer's disease
Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products ...
Medscape2h
EMA Turns Down Nurzigma for Huntington Disease
The drug failed to meet its primary endpoints in clinical trials, but subgroup analyses hinted at modest benefits.
AQNEURSA® (levacetylleucine) Recommended for EU Approval by the CHMP to Treat Niemann-Pick Disease Type C
IntraBio Inc., a biopharmaceutical company focused on developing therapies for rare neurological diseases, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products ...
Medscape1d
EMA Committee Backs Tryngolza for Rare Lipid Disorder
The opinion is based on positive data from the phase 3 Balance study, which showed a significant reduction of triglycerides ...
Agence France-Presse1d
BeOne Medicines Receives Positive CHMP Opinion for TEVIMBRA® in Neoadjuvant/Adjuvant NSCLC Treatment
BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...
Medical Dialogues2d
Roche gets negative EMA Committee opinion on Elevidys CMA for 3-7 year olds with Duchenne muscular dystrophy
Basel: Roche has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...
Pharmabiz1d
CHMP issues negative opinion on conditional marketing authorization for Roche’s gene therapy, Elevidys for Duchenne muscular dystrophy
CHMP issues negative opinion on conditional marketing authorization for Roche’s gene therapy, Elevidys for Duchenne muscular dystrophy: Basel Monday, July 28, 2025, 15:00 Hrs [I ...
KalVista Gets CHMP Backing for Ekterly in Hereditary Angioedema
KalVista on Friday said the recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use covers Ekterly in people ages 12 and older for the symptomatic treatment of ...
The Joplin Globe4d
TRYNGOLZA® (olezarsen) recommended for approval in the EU by CHMP for familial chylomicronemia syndrome (FCS)
TRYNGOLZA was approved in the United States in December 2024 and granted orphan designation in the EU. Olezarsen is also being evaluated for sHTG, a serious condition defined by dangerously high ...
Deciphera Announces Positive CHMP Opinion for ROMVIMZA™ (vimseltinib) for the Treatment of Tenosynovial Giant Cell Tumor (TGCT)
Deciphera Pharmaceuticals, LLC, a biopharmaceutical company focused on discovering, developing, and commercializing important ...
Pharmabiz1d
EMA committee recommends marketing approval for Biogen’s Zurzuvae to treat women with postpartum depression
EMA committee recommends marketing approval for Biogen’s Zurzuvae to treat women with postpartum depression: Cambridge, Massachusetts Monday, July 28, 2025, 17:00 Hrs [IST] Biog ...
Gilead Gets CHMP Backing for Twice-Yearly Treatment to Prevent HIV
Gilead on Friday said the recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use covers lenacapavir for use as pre-exposure prophylaxis, or PrEP, to reduce ...