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.
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.
CASI Pharmaceuticals’ partner Juventas Cell Therapy has received market approval from the China National Medical Products Administration (NMPA) for Inaticabtagene Autoleucel (CNCT 19).
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).