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 ...
Medscape7h
EMA Reverses Previous Refusal of Kisunla for Alzheimer's
Kisunla’s active substance is donanemab, a monoclonal antibody that targets and clears amyloid-beta plaques in the brain, a ...
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 ...
Medscape2d
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 ...
Pharmabiz15h
EMA committee recommends approval of BeOne Medicines’ Tevimbra to treat neoadjuvant/adjuvant NSCLC
EMA committee recommends approval of BeOne Medicines’ Tevimbra to treat neoadjuvant/adjuvant NSCLC: San Carlos, California Wednesday, July 30, 2025, 12:00 Hrs [IST] BeOne Medici ...
Medical Dialogues3d
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 ...
The Joplin Globe5d
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 ...
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 ...
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 ...
The Joplin Globe5d
KalVista Pharmaceuticals Receives Positive CHMP Opinion for Sebetralstat for the Treatment of Hereditary Angioedema Attacks
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion ...
Pharmabiz2d
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 ...