Regulation

GSK’s daprodustat obtains positive opinion from EMA CHMP

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion recommending authorisation of GlaxoSmithKline’s (GSK) daprodustat for symptomatic anaemia linked to chronic kidney disease (CKD).

F2G receives Complete Response Letter for olorofim NDA

F2G has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its new drug application (NDA) for olorofim to treat invasive fungal infections.

Eupraxia’s EP-104IAR secures US FDA Fast Track status

Eupraxia Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for EP-104IAR to treat osteoarthritis of the knee in adult patients.

EMA grants PRIME designation to Rocket’s AAV-based gene therapy

The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Rocket Pharmaceuticals’ adeno-associated virus (AAV)-based gene therapy, RP-A501, for the treatment of Danon Disease, a rare X-linked inherited disorder.

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).