Regulation

Novartis receives FDA approval for Fabhalta to treat PNH in adults

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).

US FDA accepts Karuna’s NDA for schizophrenia therapy

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 secures ODD and RPDD for Haemophilia A programme

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 files applications with US FDA for HLHS therapy

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).

US FDA approves Valneva’s vaccine against chikungunya virus

The US Food and Drug Administration (FDA) has granted approval for Valneva's vaccine, IXCHIQ, against the chikungunya virus.

NeoImmuneTech receives orphan drug status for NT-I7 to treat ARS

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 obtains approval from EC for atopic dermatitis therapy

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 receives ODD from EMA for anti-TNFα monoclonal antibody

Xentria has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for its anti-TNFα monoclonal antibody, XTMAB-16.

Kesin Pharma receives approval from FDA for LIKMEZ

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.