Regulation

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.

FDA accepts sNDA and grants priority review for Calliditas’ TARPEYO capsules

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).

FDA accepts Venatorx’s NDA for cefepime-taniborbactam antibiotic

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.

FDA approves nonprescription use of RiVive naloxone nasal spray

The US Food and Drug Administration (FDA) has granted approval to RiVive, developed by Harm Reduction Therapeutics, for the emergency treatment of known or suspected overdose caused due to opioid.

EC approves AstraZeneca’s Soliris to treat refractory gMG in children, adolescents

The European Commission (EC) has granted approval for AstraZeneca’s Soliris (eculizumab) to treat refractory generalised myasthenia gravis (gMG) in children and adolescents.