Drug Approval | June 01, 2024
Moderna receives U.S. FDA approval for RSV Vaccine mRESVIA
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue
Breakthrough Therapy designation for pain associated with DPN granted by FDA
WINREVAIR is a breakthrough biologic for this rare, progressive disease
Clinical findings support the safety and efficacy of BMND08 at a maximum dosage of 12mg
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease
Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
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