Regulation

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.

US FDA grants BeOne’s sonrotoclax breakthrough designation for MCL

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).

Adcendo receives FDA fast track status for ADCE-D01 to treat STS

Adcendo has secured fast track designation from the US Food and Drug Administration (FDA) for ADCE-D01 to treat soft tissue sarcoma (STS).

Bio-Thera, Intas extend partnership for golimumab biosimilar

Bio-Thera Solutions has expanded its partnership with Intas Pharmaceuticals through a licence agreement and exclusive commercialisation for BAT2506, a proposed golimumab biosimilar, in Canada.

FDA accepts priority review for Orca Bio’s hematological malignancy therapy

The US Food and Drug Administration (FDA) has accepted priority review of Biologics Licence Application (BLA) for Orca Bio’s lead investigational allogeneic T-cell immunotherapy Orca-T.