Approvals

SELLAS receives orphan drug designation for PTCL therapy

SELLAS Life Sciences Group has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SLS009, a new CDK9 inhibitor aimed at treating relapsed/refractory Peripheral T-cell Lymphomas (PTCL).

Calliditas receives approval for Nefecon to treat IgAN

The US Food and Drug Administration (FDA) has granted full approval for Calliditas Therapeutics’ Nefecon, a treatment licensed by Everest Medicines, for adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.

Arcutis Biotherapeutics receives FDA approval for ZORYVE to treat seborrheic dermatitis

Arcutis Biotherapeutics has received US Food and Drug Administration (FDA) approval for the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3%, to treat seborrheic dermatitis in individuals aged nine-years and older.

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).

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.

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.