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 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 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).
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 is set take over the European commercialisation of Byooviz (ranibizumab) from January 2026 under an asset purchase agreement (APA) with Biogen.
Biogen has entered into a licence agreement securing global rights to Vanqua Bio’s oral, preclinical C5aR1 antagonist.
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.
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).
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.
BeOne Medicines has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for sonrotoclax, an investigational, next-generation BCL2 inhibitor intended for adults with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
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