Shots:
FDA has approved Wegovy (25mg, QD, PO) for weight loss, chronic weight management & major adverse CV events risk reduction in adults with obesity/overweight; US availability expected in early Jan 2026. Regulatory filing is made to the EMA & other authorities in H2’25
Approval was based on the P-IIIb (OASIS 4) trial assessing oral…
NEWS
Shots:
Windward Bio via its affiliate, LE2025 Therapeutics, has entered into a licensing agreement with Qyuns to develop & commercialize WIN027 (QX027N; anti-TSLPxIL-13 bsAb)
As per the deal, Windward will obtain exclusive rights to develop, manufacture, & commercialize WIN027 outside of China, with Qyuns receiving an upfront payment, equity, & development, regulatory, & commercial milestones,…
Shots:
Shionogi to acquire a newly established company that will be created by Tanabe Pharma to hold the rights to Radicava ORS (edaravone) & IV Radicava
As per the deal, Tanabe Pharma will establish a new entity, & Shionogi will acquire 100% of its shares, with Tanabe’s US Radicava business company becoming a wholly owned…
Shots:
The MHLW has approved Incyte’s Minjuvi + rituximab & lenalidomide for the treatment of adults with r/r FL (Grade 1-3a) who received ≥1L of systemic therapy
Approval was based on the P-III (inMIND) trial (N=654) assessing Minjuvi combination vs PBO + rituximab & lenalidomide in r/r FL or r/r nodal, splenic or extranodal MZL…
Shots:
The US FDA has approved Roche’s Lunsumio VELO (mosunetuzumab) as an SC formulation for the treatment of adults with r/r follicular lymphoma (FL) after ≥2L of systemic therapy, under accelerated approval
Approval was based on the P-I/II (GO29781) study in third-line or later FL pts, where Lunsumio VELO demonstrated an ORR of 75% and…
Shots:
Samsung Bioepis has received Japanese marketing approval for Ustekinumab BS 45mg syringes, a biosimilar of Stelara, under its partnership with NIPRO Corporation
Ustekinumab, a human IgG1κ antibody targeting IL-12/IL-23, is approved in Japan as ‘NIPRO’ for plaque psoriasis and psoriatic arthritis, with NHI listing expected in May 2026
It is also approved in Australia, Brazil, Canada,…
Shots:
Biocon Biologics secured full global rights to Hulio (Adalimumab), a biosimilar of adalimumab, from Fujifilm Kyowa Kirin Biologics
As per the agreement, Biocon Biologics will take full responsibility for manufacturing, commercialization, and further development, while FKB will support development, offset certain development costs, and receive technology license fees and royalties for a specified tenure
Biocon Biologics…
Shots:
The US FDA has approved Nufymco (ranibizumab-leyk), an interchangeable biosimilar of Lucentis, with Zydus serving as its commercialization partner in the US
Nufymco is an interchangeable Lucentis biosimilar developed by Formycon, approved for the treatment of wet AMD, diabetic macular edema, diabetic retinopathy, retinal vein occlusion-related macular edema, and myopic choroidal neovascularization
Zydus secured exclusive US and Canada rights to Formycon’s Keytruda…
Shots:
The NMPA has approved Merck KGaA's Pimicotinib (PO) for the treatment of adults with symptomatic TGCT, where surgical resection can lead to functional limitation or relatively severe morbidity
Approval was based on the global 3-part P-III (MANEUVER) trial in TGCT pts who require systemic therapy & have not received prior anti-CSF-1/CSF-1R therapy, in which…
Shots:
Alvotech has reported the launch of Gobivaz (AVT05), a biosimilar version of Simponi (golimumab) for the treatment of several chronic inflammatory diseases, with commercialization led by Advanz Pharma
In the UK, Gobivaz’s launch is supported by an NHS England tender award, while rollout across EEA markets will advance in line with country-specific pricing, reimbursement…

