Regulation

FDA committee backs Pfizer’s RSV vaccine candidate for infants

The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted in favour of Pfizer’s unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate, RSVpreF or PF-06928316.

Chiesi, Protalix’s PRX-102 secure FDA nod to treat Fabry disease

Chiesi Global Rare Diseases and Protalix BioTherapeutics have received approval from the US Food and Drug Administration (FDA) for PRX-102 (pegunigalsidase alfa) to treat Fabry disease in adult patients.

US FDA declines to approve Ascendis Pharma’s TransCon PTH NDA

The US Food & Drug Administration (FDA) has declined to approve Ascendis Pharma’s New Drug Application (NDA) for TransCon PTH (palopegteriparatide) to treat hypoparathyroidism in adult patients.

Health Canada approves Arcutis Biotherapeutics’ Zoryve for Plaque Psoriasis

Health Canada has granted approval to Arcutis Biotherapeutics’ Zoryve (roflumilast) cream 0.3% to treat people aged 12 years and above with Plaque Psoriasis.

Amicus gets positive CHMP opinion for Opfolda to treat late-onset Pompe disease

Amicus Therapeutics has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Opfolda (miglustat) to treat late-onset Pompe disease (LOPD).

Ardelyx resubmits NDA for Xphozah to US FDA

Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA).

FDA grants orphan drug designation to HuidaGene gene therapy for blindness

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to HuidaGene Therapeutics’ HG004 gene replacement therapy.

Daiichi Sankyo receives approval for ENHERTU in Japan

Daiichi Sankyo has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for ENHERTU (trastuzumab deruxtecan), a treatment for adult patients with HER2 low (IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy.

Iovance Biotherapeutics submits BLA to FDA for advanced melanoma drug lifileucel

Iovance Biotherapeutics has completed submission of the Biologics License Application (BLA) for lifileucel to the US Food and Drug Administration (FDA).