FDA approves Fluad Quadrivalent adjuvanted seasonal influenza vaccine.- Seqirus/CSL
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Genentech, a member of the Roche Group announced that the FDA has approved a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis).
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Xofluza, intended for the treatment and post-exposure prophylaxis of uncomplicated influenza.
The European Commission has granted a marketing authorization for Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine, from Sanofi, for the prevention of influenza in adults aged 18 years and older.