Regulation

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).

Saptalis Pharmaceuticals receives FDA approval for metronidazole oral suspension

The US Food and Drug Administration (FDA) has granted approval to New York-based specialty pharmaceuticals company Saptalis Pharmaceuticals for metronidazole oral suspension 500mg/5mL (ATI-1501).

Sanofi gets Japanese authorisation for factor VIII therapy for hemophilia A

Sanofi has received marketing authorisation from the Japanese Ministry of Health, Labor, and Welfare (MHLW) for ALTUVIIIO, a first-in-class, high-sustained factor VIII replacement therapy for controlling blood loss in hemophilia A patients.

FDA approves Krystal Biotech’s KB408 for AATD treatment

The US Food and Drug Administration (FDA) has granted clearance to Krystal Biotech’s investigational new drug application (IND) for KB408 to treat alpha-1 antitrypsin deficiency (AATD), a rare genetic disease.

ViiV Healthcare receives European Commission approval for Apretude

ViiV Healthcare has received authorisation from the European Commission for Apretude (cabotegravir long-acting (LA) injectable and tablets) to prevent HIV.

UK’s NICE recommends QUVIVIQ to treat chronic insomnia in adults

The National Institute for Health and Care Excellence (NICE) has recommended Idorsia UK’s QUVIVIQ (daridorexant) to treat chronic insomnia in adults.