Regulation

March Bio’s MB‑105 gains FDA RMAT for CD5+ T‑cell lymphoma

March Biosciences (March Bio) has received US Food and Drug Administration (FDA) regenerative medicine advanced therapy (RMAT) designation for MB-105, an autologous CD5-targeted CAR-T cell therapy under development for relapsed/refractory CD5-positive T-cell lymphoma.

Alvotech and Advanz announce MHRA marketing authorisations for Gobivaz

Alvotech and Advanz Pharma have announced the receipt of marketing authorisations from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for all four formulations of Gobivaz – Alvotech’s biosimilar to Simponi (golimumab).

Leukogene Therapeutics gains FDA ODD status for M2T-CD33

Leukogene Therapeutics has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for M2T-CD33 (LTI-214), its immunotherapy candidate targeting acute myeloid leukaemia (AML).

Calluna secures FDA orphan drug designation for CAL101 in IPF

Norway-based biotechnology company Calluna Pharma has received orphan drug designation from the US Food and Drug Administration (FDA) for its lead clinical candidate, CAL101.

Samsung Bioepis to acquire commercial rights for Byooviz in Europe

Samsung Bioepis is set take over the European commercialisation of Byooviz (ranibizumab) from January 2026 under an asset purchase agreement (APA) with Biogen.

Biogen acquires global rights to Vanqua C5aR1 antagonist

Biogen has entered into a licence agreement securing global rights to Vanqua Bio’s oral, preclinical C5aR1 antagonist.

Boehringer’s Jascayd gains NMPA approval for idiopathic pulmonary fibrosis

China’s National Medical Products Administration (NMPA) has granted approval to Boehringer Ingelheim’s Jascayd (nerandomilast) as an oral treatment for idiopathic pulmonary fibrosis (IPF) in adults.

Portal Therapeutics receives FDA orphan, fast track designations for PORT-77

GondolaBio’s affiliate Portal Therapeutics has received orphan drug and fast track designations from the US Food and Drug Administration (FDA) for PORT-77, an investigational oral ABCG2 inhibitor, aimed at treating X-linked protoporphyria (XLP) and erythropoietic protoporphyria (EPP).

FDA accepts Chiesi triple combination inhaler application for asthma

Chiesi USA has announced the US Food and Drug Administration (FDA) acceptance for its New Drug Application (NDA) for triple combination inhaler for the maintenance treatment of asthma in adults.