Regulation - Approvals

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.

Kesin Pharma receives approval from FDA for LIKMEZ

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.

Lipella Pharmaceuticals gets ODD for LP-310 to treat GvHD

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 receives FDA approval for chikungunya vaccine

Valneva Austria has received approval from the US Food and Drug Administration (FDA) for Ixchiq, the first chikungunya vaccine.

Mirati receives approval from UK’s MHRA for NSCLC therapy

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 receives orphan drug designation for systemic sclerosis therapy

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).