Regulation

Merck gets FDA approval for WELIREG to treat advanced renal cell carcinoma

Merck, known as MSD outside of the US, and Canada, today announced that receipt of the US Food and Drug Administration (FDA) approval for WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor for the treatment of adult patients with advanced renal cell carcinoma (RCC).

USFDA accepts NextPoint Therapeutics’s IND for NPX887

NextPoint Therapeutics has announced that its investigational new drug (IND) application has been accepted by the US Food & Drug Administration (FDA) for NPX887.

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).