Abeona Therapeutics has announced receipt of the US Food and Drug Administration (FDA) approval for gene-modified cellular sheet therapy Zevaskyn for the wound treatment in both adult and paediatric patients suffering from recessive dystrophic epidermolysis bullosa (RDEB), a serious genetic skin condition.
Health Canada has granted approval for Arcutis’ topical formulation Zoryve (roflumilast cream 0.15%) for mild to moderate atopic dermatitis (AD) treatment in adults and paediatrics aged six years and above.
DEBRA Research and LEO Pharma have announced a non-exclusive strategic collaboration aiming to improve scouting capabilities and offer extra capacity to propel the development of therapies for Epidermolysis Bullosa (EB).
Torii Pharmaceutical has submitted a new drug application (NDA) for TO-208 in Japan, targeting the treatment of molluscum contagiosum, a common and highly contagious skin disease.
The US Food and Drug Administration (FDA) has accepted for review the supplemental biologics license application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) to treat chronic spontaneous urticaria (CSU) in adults and children aged 12 and above, particularly for those whose condition persists despite H1 antihistamine treatment.
The US Food and Drug Administration (FDA) has granted approval for Fresenius Kabi and Formycon’s Otulfi (ustekinumab-aauz), a ustekinumab biosimilar to the reference medicine Stelara (ustekinumab).
Hyphens Pharma has launched Ceradan Advanced Hand Balm, a new addition to its skincare range, specifically designed to combat hand eczema.
Azitra has received the US Food and Drug Administration (FDA) fast track designation to its product ATR-04 for the treatment of skin rash from Epidermal Growth Factor Receptor (EGFR) inhibitors.
The National Medical Products Administration (NMPA) of China has approved Keymed Biosciences’ new drug application granting marketing approval for Stapokibart to treat adults with moderate-to-severe atopic dermatitis.
LEO Pharma has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval for Anzupgo (delgocitinib cream) for adults with moderate to severe chronic hand eczema (CHE).
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