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 ...
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 ...
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 ...
PharmiWeb3d
GSK’s Shingrix new prefilled syringe presentation accepted for review by European Medicines Agency
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK’s Recombinant ...
Daily2d
GSK Shingrix new prefilled syringe presentation accepted for review by EMA
London: GSK plc has announced that the European Medicines Agency (EMA) has accepted for review the regulatory application of ...
Pharmabiz1d
EMA accepts for review regulatory application of GSK’s Shingrix new prefilled syringe presentation for prevention of shingles
EMA accepts for review regulatory application of GSK’s Shingrix new prefilled syringe presentation for prevention of shingles: London, UK Wednesday, January 29, 2025, 13:00 Hrs ...
ots6d
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor - licenced to Norgine for commerc
Following the licensing agreement with X4 Pharmaceuticals, Norgine is pleased to see the announcement from X4 today that their Marketing Authorization Application (MAA) for ...
FDA Approves Once-Every-Four-Weeks Maintenance Dosing Of LEQEMBI For Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced Sunday that the U.S. Food and Drug Administration has approved the ...
Biogen Inc.: FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMA CAMBRIDGE, Mass., Jan. 2 ...
FDA and EMA review Biogen's higher dose SMA drug
CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...