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.
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.
Clinical stage pharmaceutical company Lipella Pharmaceuticals has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its drug candidate, LP-310, which is intended to treat oral Graft-versus-Host Disease (GvHD).
Valneva Austria has received approval from the US Food and Drug Administration (FDA) for Ixchiq, the first chikungunya vaccine.
Mirati Therapeutics has received conditional marketing authorisation approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its advanced non-small cell lung cancer (NSCLC) therapy, Krazati (adagrasib).
Certa Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for its investigational therapy, FT011, to treat systemic sclerosis (scleroderma).