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EMA approves addition of sites to Greenwich LifeSciences’ breast cancer trial
The European Medicines Agency (EMA) has approved the expansion of Greenwich LifeSciences’ Phase III FLAMINGO-01 breast cancer ...
pharmaphorum4y
EMA clears compassionate use of Gilead’s remdesivir for COVID-19
The EMA’s human medicines committee (CHMP) says the antiviral drug can be used on compassionate-use grounds for people with severe coronavirus complications, such as pneumonia, acute respiratory ...
pharmaphorum4d
CHMP backs J&J's myeloma bispecific Tecvayli, ahead of US decision
The EMA's human medicines committee has recommended approval of Johnson & Johnson's Tecvayli as a fourth-line therapy for multiple myeloma, joining a growing group of BCMA-targeted therapies for ...
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor for the Treatment of WHIM Syndrome
Submission supported by positive results from global, Phase 3 4WHIM clinical trial; U.S. regulatory approval in WHIM syndrome ...
Pharmabiz3d
EMA validates X4 Pharma’s marketing authorization application for mavorixafor to treat WHIM syndrome
EMA validates X4 Pharma’s marketing authorization application for mavorixafor to treat WHIM syndrome: Boston Monday, January 27, 2025, 11:00 Hrs [IST] X4 Pharmaceuticals, a comp ...
X4 Pharmaceuticals announces EMA validation of MAA for mavorixafor
X4 Pharmaceuticals (XFOR) announced that its Marketing Authorization Application for mavorixafor for the treatment of WHIM syndrome, a rare ...
Too Old to Operate8d
Surrogate Endpoints in Expedited Approval Challenges and Trends
Unveiling oncology and non-oncology drug approvals and withdrawals of USFDA and EMA,” published in the January 2025 issue of ...