Regulation

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.

US FDA issues guidance for Citius’ lymphoma treatment BLA

The US Food and Drug Administration (FDA) has issued additional guidance to Citius Pharmaceuticals on the resubmission of a biologics license application (BLA) for Lymphir (denileukin diftitox) to treat cutaneous T-cell lymphoma (CTCL).

Mallinckrodt announces FDA approval for Lisdexamfetamine Dimesylate Capsules

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 gets approval in Japan for calcimimetics agent Orkedia Tablets 4mg

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.

FDA grants orphan drug designation to Faron’s bexmarilimab

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Faron Pharmaceuticals’ bexmarilimab to treat acute myeloid leukemia (AML).

Akeso receives priority review of ivonescimab NDA in China

Akeso has received the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China’s (NMPA CDE) priority review of new drug application (NDA) for its antibody ivonescimab.