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.
29 Sep 2023
28 Sep 2023
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).
27 Sep 2023
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).
26 Sep 2023
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.
22 Sep 2023
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.
20 Sep 2023
ViiV Healthcare has received authorisation from the European Commission for Apretude (cabotegravir long-acting (LA) injectable and tablets) to prevent HIV.
18 Sep 2023
The National Institute for Health and Care Excellence (NICE) has recommended Idorsia UK’s QUVIVIQ (daridorexant) to treat chronic insomnia in adults.
11 Sep 2023
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).
01 Sep 2023
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.
31 Aug 2023
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.