The FDA on Friday approved Takeda and Protagonist Therapeutics' Mimrylo (rusfertide) to treat adults with polycythemia vera (PV), making it the first hepcidin mimetic cleared to treat the rare blood disorder. Current treatment options for PV, like hydroxyurea and interferons, as well as Incyte's Jakafi (ruxolitinib), are "ineffective in a majority of patients," Protagonist President and CEO Dinesh Patel previously told FirstWord. Patients have also historically relied on phlebotomies to keep th

In their high-profile competition in the diabetes and obesity markets, Eli Lilly has proven adept at playing catch-up with Novo Nordisk. On Friday, Lilly checked another item off that list as it secured FDA approval for Mounjaro to reduce the risk of major adverse cardiovascular events (MACE), including CV death, heart attack or stroke, in at-risk adults with Type 2 diabetes. With the nod, Lilly matches the 2020 approval Novo received for its diabetes treatment, Ozempic, to lower the risk of ad

TSY-110 is positioned to become the first biosimilar alternative to Roche's Kadcyla® (ado-trastuzumab emtansine) in major regulated markets. Aug. 28, 2026 -- Formosa Pharmaceuticals, Inc. (TWSE: 6838), today announced the submission of a Clinical Trial Application (CTA) to European regulatory authorities to conduct a pivotal clinical trial for TSY-110. TSY-110 is a biosimilar candidate referencing Roche's antibody-drug conjugate (ADC) Kadcyla® (ado-trastuzumab emtansine), indicated for HER2-pos

Aug. 28, 2026 -- InxMed Co., Ltd ("InxMed"), a clinical-stage biotechnology company dedicated to developing innovative therapies targeting cancer treatment resistance and metastasis, today announced that the clinical results of ifebemtinib (IN10018), a highly selective focal adhesion kinase (FAK) inhibitor, in combination with garsorasib (D-1553), a potent KRAS G12C inhibitor, in previously treated KRAS G12C-mutant metastatic colorectal cancer (CRC), have been published online in The Lancet Onco

Roche’s Genentech is paying DualityBio $45 million upfront for rights to antibody-drug conjugates (ADCs) designed for the growing pool of patients who progress after treatment with the modality. The deal is worth more than $1 billion in potential milestones. Approved ADCs such as AstraZeneca and Daiichi Sankyo’s Enhertu and Gilead’s Trodelvy deliver cytotoxic topoisomerase inhibitors to cells that express certain receptors. As the ADCs move into earlier lines of therapy—Enhertu and Trodelvy are

AusperBio on Thursday said it successfully concluded a $120-million series C financing to advance its portfolio of investigational oligonucleotide therapeutics for chronic hepatitis B (CHB). The latest round was led by an unnamed strategic investor, with new participation from RA Capital Management, alongside existing backers HanKang Capital, Sherpa Capital, InnoPinnacle Fund, Qiming Venture Partners, YuanBio Venture Capital and CDH Investments. Proceeds from the latest round will support the

MZ‑1866 Phase 1/2 UNITE Study is now more than 50% enrolled Aug. 25, 2026 -- Mahzi Therapeutics Inc., a clinical-stage biotechnology company developing precision therapies for neurogenetic disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to MZ-1866, Mahzi's investigational gene therapy for the treatment of Pitt Hopkins syndrome. The designation was granted by the FDA's Office of Orphan Products Development and Off

Aug. 21, 2026 -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) today announced the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Opamtistomig (LBL-024), the Company's proprietary PD-L1/4-1BB bispecific antibody, as a monotherapy for the treatment of previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). Opamtistomig is the first PD-L1/4-1

GSK is looking to expand its COPD biologics franchise beyond IL-5 blockade, kicking off two Phase III studies of its long-acting anti-TSLP antibody felcorekibart (GSK5784283/AIO-001). Sanofi and Regeneron's IL-4/IL-13 inhibitor Dupixent (dupilumab) and GSK's IL-5 inhibitor Nucala (mepolizumab) are currently the only approved biologics for the condition. Earlier this year, CEO Luke Miels singled out felcorekibart as one of the pipeline programmes that could help GSK raise its game (see – Spotli

If at first you don’t succeed in gene therapy, then try, try again. That's the lesson Ultragenyx likely took home this week as it pocketed its first FDA nod in the class just over a year after a separate program stalled on manufacturing grounds. Late Wednesday, the FDA gave an accelerated go-ahead to pariglasgene brecaparvovec-opnr, Ultragenyx’s AAV gene therapy for the rare genetic disorder glycogen storage disease type Ia (GSDIa), which will now head to market with the brand name Genglycos.