Novartis has announced that the US Food and Drug Administration (FDA) has given approval to Fabhalta (iptacopan) as the first oral monotherapy to treat adults suffering with paroxysmal nocturnal hemoglobinuria (PNH).
The US Food and Drug Administration (FDA) has accepted Karuna Therapeutics’ new drug application (NDA) for KarXT (xanomeline-trospium) to treat schizophrenia in adults.
Sernova has secured orphan drug designation (ODD) and rare paediatric disease designation (RPDD) from the US Food and Drug Administration (FDA) for its Haemophilia A programme.
Mesoblast has filed an application with the US Food and Drug Administration (FDA) seeking orphan drug and rare paediatric disease designations for its allogeneic cell therapy, Revascor (rexlemestrocel-L), to treat congenital heart disease hypoplastic left heart syndrome (HLHS).
The US Food and Drug Administration (FDA) has granted approval for Valneva's vaccine, IXCHIQ, against the chikungunya virus.
NeoImmuneTech has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug, NT-I7 (efineptakin alfa) (rhIL-7-hyFc), to treat Acute Radiation Syndrome (ARS), an acute illness.
Almirall has obtained approval from the European Commission (EC) for EBGLYSS (lebrikizumab) to treat adult and adolescent patients with moderate-to-severe atopic dermatitis (AD).
Xentria has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for its anti-TNFα monoclonal antibody, XTMAB-16.
Kesin Pharma has received approval from the US Food and Drug Administration (FDA) for its new liquid formulation of metronidazole, LIKMEZ oral suspension, 500 mg/5 mL.
Clinical stage pharmaceutical company Lipella Pharmaceuticals has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its drug candidate, LP-310, which is intended to treat oral Graft-versus-Host Disease (GvHD).
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