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.
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).
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 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.
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 has received authorisation from the European Commission for Apretude (cabotegravir long-acting (LA) injectable and tablets) to prevent HIV.
The National Institute for Health and Care Excellence (NICE) has recommended Idorsia UK’s QUVIVIQ (daridorexant) to treat chronic insomnia in adults.
Mallinckrodt has announced the US Food and Drug Administration (FDA) approval for its abbreviated new drug application for Lisdexamfetamine Dimesylate Capsules in strengths 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg.
Kyowa Kirin has secured approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Orkedia Tablets 4mg, the generic name of which is evocalcet.
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