Hosted on MSN22h
EMA approves Takeda’s Takhzyro pre-filled pen option for HAE
The European Medicines Agency (EMA) has approved an additional 2 mL pre-filled pen option for subcutaneous administration of ...
Hosted on MSN1d
Gilead’s lenacapavir applications for HIV gain EMA validation
Gilead Sciences has announced the European Medicines Agency’s (EMA) validation for a parallel accelerated review of ...
Business Wire2d
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 ...
centerforbiosimilars23h
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their ...
Drug companies and Minister agree medicines need to be available to patients more quickly
Patients should have faster access to newly developed drugs and medicines and the Government is prepared to adopt new ...
Gilead announces European Medicines Agency validation for lenacapavir
Gilead (GILD) announced that the European Medicines Agency has validated for parallel accelerated review the company’s marketing authorization ...
Medical Xpress6d
European study highlights inequalities in diagnosis and treatment of biliary tract cancer
One of the main challenges identified by the research was that, although the European Medicines Agency (EMA) approves new ...
European Commission Approves CSL and Arcturus Therapeutics' KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine
Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today ...
Pharmabiz1d
EMA validates Gilead’s MAA and EU-Medicines for all application for twice-yearly lenacapavir for HIV prevention
Foster City, California Tuesday, February 25, 2025, 16:00 Hrs [IST] ...