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).
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.
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.
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.