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FDA approves expanded use of Moderna’s RSV shot, but uncertainty remains
The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include people 18 to 59 years old who are at increased risk for severe illness from ...
FDA expands approval of Moderna's RSV vaccine to some adults under age 60
The FDA expanded its approval of Moderna's RSV vaccine on Thursday to include adults under age 60 at increased risk of the ...
BioPharma Dive1 lá
Moderna wins FDA OK to widen use of RSV vaccine
The agency’s decision to clear Moderna’s shot for use in certain younger adults is a much-needed win for a company that’s ...
FDA clears Moderna’s RSV vaccine for use in people ages 18 to 59
The Food and Drug Administration expanded the approval of Moderna’s RSV vaccine on Thursday, extending the license to include ...
Pharmaceutical Technology on MSN1 lá
Moderna’s mRNA RSV vaccine wins expanded FDA approval for younger adults
The label expansion for Moderna’s jab arrives at a juncture in America’s changing vaccine regulatory landscape.
BioPharma Dive5 lá
Merck antibody drug for RSV approved by FDA
Known as Enflonsia, the drug will compete for market share with Sanofi and AstraZeneca’s in-demand Beyfortus, which quickly ...
Fierce Pharma5 lá
Merck scores FDA nod for Enflonsia, setting up RSV market battle vs. Sanofi and AstraZeneca's Beyfortus
Meanwhile, Sanofi has pointed to Beyfortus’ 75% reduction in the incidence of MALRI versus Enflosia’s figure of 60%. The ...
Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at Increased Risk for RSV Disease
Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS ...
Clinical Trials Arena3 lá
MSD’s Enflonsia receives FDA approval for RSV prophylaxis
Merck’s Enflonsia (clesrovimab) has received US Food and Drug Administration (FDA) approval for the prevention of respiratory ...
The Pharma Letter1 lá
FDA nod for Moderna’s RSV Vaccine, mRESVIA for younger adults
US mRNA specialist Moderna today announced that the US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), ...
Healio4 lá
FDA approves clesrovimab for preventing RSV in infants
The FDA approved the monoclonal antibody clesrovimab-cfor for the prevention of respiratory syncytial virus lower respiratory ...
PMLive4 lá
Merck’s RSV monoclonal antibody Enflonsia approved by FDA to protect infants
Merck & Co – known as MSD outside the US and Canada – has announced that its respiratory syncytial virus (RSV) preventive ...