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