Regulation

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).

UK’s NICE recommends Brukinsa to treat adults with CLL

BeiGene has received a positive recommendation from the UK’s National Institute for Health and Care Excellence (NICE) for Brukinsa (zanubrutinib) to treat adults with chronic lymphocytic leukaemia (CLL).

Hyloris’ Maxigesic IV receives FDA approval for pain management

Hyloris Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for new drug application (NDA) for Maxigesic IV to manage pain.

China accepts CANbridge’s NDA for CAN108 to treat cholestatic pruritus in PFIC

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).

United Medical secures pricing approval for Minjuvi in Brazil

Specialty pharmaceutical company Knight Therapeutics’s Brazilian affiliate, United Medical, has secured pricing approval for Minjuvi (tafasitamab) from the Drugs Market Regulation Chamber (CMED).

FDA clears Kyverna’s IND for scleroderma therapy

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).

Taiwan approves CANbridge’s CAN108 for treatment of cholestatic pruritus

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.

Merck gains FDA priority review for sotatercept BLA

The US Food and Drug Administration (FDA) has accepted Merck’s (MSD) biologics license application (BLA) of sotatercept to treat pulmonary arterial hypertension [PAH (WHO Group 1)], for priority review.

IDEAYA receives fast track designation for breast cancer therapy

IDEAYA Biosciences has received fast track designation from the US Food and Drug Administration (FDA) for its breast cancer therapy, IDE161, which is a potent and selective inhibitor of poly (ADP-ribose) glycohydrolase (PARG).