AstraZeneca/Sanofi’s Beyfortus (nirsevimab) is on track to become the first preventative option for respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants following the European Medicines Agency’s recommendation that it be granted EU-wide marketing approval.
EMA OKs First Drug To Prevent RSV Infection In Babies
Takeda Pulls EU Filing For Exkivity To Prevent CHMP Rejection
A new medicine to protect newborns and infants from RSV infection and a new treatment for DLBCL are among a dozen drugs that have been recommended for pan-EU approval.
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The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
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US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease