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.
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 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.
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Faron Pharmaceuticals’ bexmarilimab to treat acute myeloid leukemia (AML).
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.
The US Food and Drug Administration (FDA) has accepted Calliditas Therapeutics’ supplemental New Drug Application (sNDA) submission and granted priority review for full approval of TARPEYO (budesonide) delayed release capsules to treat IgA nephropathy (IgAN).
The US Food and Drug Administration (FDA) has accepted Venatorx Pharmaceuticals’ new drug application (NDA) for cefepime-taniborbactam antibiotic for the potential treatment of complicated urinary tract infections (cUTI) including pyelonephritis, in adults.
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