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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.

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The regulatory round-up: Five important FDA approvals

Drug Discovery World

The US Food and Drug Administration (FDA) has granted marketing authorisations to several new therapeutics over the last month that will have a significant impact on areas of unmet need and the evolution of future treatments.

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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

The news highlights this week all centre around significant US Food and Drug Administration (FDA) regulatory decisions, including new approvals for drugs for solid tumours, hepatitis B and glioma. The post This week in drug discovery (5-9 August) appeared first on Drug Discovery World (DDW).

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This week in drug discovery (12-16 June)  

Drug Discovery World

Regulatory approvals and industry guidelines are key to the continued development and discovery of drugs, which is a common theme throughout this week’s news highlights, including an FDA approval for Pfizer, a NICE recommendation for AstraZeneca UK, and an update to the HER2 Breast Cancer Testing Guidelines.