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).
AOB Pharma has signed an exclusive license and development agreement with Maruho for the development and marketing of its topical biologic, B244, for inflammatory indications in Japan.
The National Medical Products Administration (NMPA) of China has accepted the new drug application (NDA) submitted by CANbridge Pharmaceuticals for CAN108 (Maralixibat Chloride Oral Solution/ LIVMARLI) for the treatment of cholestatic pruritus in patients aged two months and above with progressive familial intrahepatic cholestasis (PFIC).
The US Food and Drug Administration (FDA) has granted clearance to Kyverna Therapeutics’ investigational new drug (IND) application enabling initiation of the Phase I/II KYSA-5 trial of KYV-101 to treat diffuse cutaneous systemic sclerosis (scleroderma).
The Taiwan Food and Drug Administration (TFDA) has granted marketing approval to CANbridge Pharmaceuticals’ CAN108 (Maralixibat Chloride Oral Solution/LIVMARLI) for the treatment of cholestatic pruritus in patients with alagille syndrome (ALGS), a rare genetic disorder.
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