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FDA approves first vaccine for respiratory syncytial virus

Drug Discovery World

The US Food and Drug Administration (FDA) has approved Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo in individuals 60 years and older. The post FDA approves first vaccine for respiratory syncytial virus appeared first on Drug Discovery World (DDW).

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FDA approves first gene therapy for Duchenne muscular dystrophy

Drug Discovery World

The Food and Drug Administration (FDA) has granted accelerated approval to Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus (AAV) based gene therapy for the treatment of DMD. The post FDA approves first gene therapy for Duchenne muscular dystrophy appeared first on Drug Discovery World (DDW).

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FDA approves RSV vaccine to protect babies from birth

Drug Discovery World

The US Food and Drug Administration (FDA) has approved the first vaccine for pregnant individuals to prevent respiratory syncytial virus (RSV) in infants. The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals 60 years of age and older. “The

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The regulatory round-up: Five important FDA approvals

Drug Discovery World

The FDA granted accelerated approval to the adeno-associated virus (AAV) based gene therapy for the treatment of ambulatory paediatric patients aged four through five years with DMD with a confirmed mutation in the DMD gene based on expression of Elevidys micro-dystrophin.

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FDA approves first gene therapy for rare skin disorder

Drug Discovery World

The US Food and Drug Administration has approved Krystal Biotech’s Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of dystrophic epidermolysis bullosa (DEB). The post FDA approves first gene therapy for rare skin disorder appeared first on Drug Discovery World (DDW).

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This week in drug discovery (5-9 August) 

Drug Discovery World

Recombinant polyclonal drug trial for HBV gets FDA green light The US Food and Drug Administration (FDA) has cleared GigaGen’s application to initiate a Phase I trial of its polyclonal drug for the treatment of hepatitis B virus (HBV) infection, GIGA-2339.

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US approves first mRNA vaccine since Covid-19

Drug Discovery World

The US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

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