European regulators to review GSK's asthma drug Nucala to treat COPD
The European Medicines Agency will review GSK's request to approve its asthma drug Nucala as an additional treatment for ...
Crinetics gets EMA approval for paltusotine marketing authorization application
Crinetics (CRNX) announced that the European Medicines Agency has validated the marketing authorization application for paltusotine, the first ...
Reuters6mon
European Medicines Agency
European regulators to review GSK's asthma drug Nucala to treat COPD The European Medicines Agency will review GSK's request to approve its asthma drug Nucala as an additional treatment for ...
Business Wire1mon
European Medicines Agency Validates Gilead’s Marketing Authorization Application and EU-Medicines for All Application for Twice-Yearly Lenacapavir for HIV Prevention
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s ...
Healio1mon
European Medicines Agency recommends ‘landmark’ gene therapy for epidermolysis bullosa
Please check back soon for updates. The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of Vyjuvek for the treatment of wounds in patients ...
CHMP Recommends Against Approval of Eli Lilly's Kisunla Alzheimer's Drug -- Update
A key European regulatory committee has recommended against approval of Eli Lilly's Kisunla, saying the benefits of the Alzheimer's disease drug don't outweigh its risks. The European Medicines Agency ...
Eli Lilly's Alzheimer's drug rejected in Europe
The EU medicines regulator on Friday rejected Eli Lilly's Alzheimer's drug, saying the treatment's ability to slow cognitive ...
Eli Lilly's Alzheimer's drug is rejected by EU regulators over brain swelling risk, despite U.S. approval
The European Union’s health regulator on Friday rejected Eli Lilly’s (LLY) Alzheimer’s drug, Kisunla, citing risks of brain ...