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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 ...
GlobalData on MSN22h
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 ...
centerforbiosimilars12h
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 ...
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 ...
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 ...
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] ...
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 ...
U.S. News & World Report1mon
EU Medicines Agency Quits X, Moves to Bluesky
AMSTERDAM (Reuters) - The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming the latest organisation to quit a social media ...
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 ...
C3i Center, a Canadian company, receives approval from the EMA to manufacture cell therapy products for the European market
C3i became the first contract development and manufacturing organization (CDMO) for cell and gene therapies in Canada to obtain a Drug Establishment License (DEL) to produce life-saving cell therapies ...