The first patient has been dosed in the TROPION-Urothelial04 phase 3 trial evaluating Datroway® (datopotamab deruxtecan) plus rilvegostomig or Datroway monotherapy versus current standard of care (durvalumab monotherapy or nivolumab monotherapy or enfortumab vedotin plus pembrolizumab) as an adjuvant treatment (after surgery) in patients with muscle invasive urothelial cancer (MIUC) at high risk of recurrence following radical surgical resection with or without prior neoadjuvant therapy. Datrow

COVID-19 remains a public health challenge, particularly among older adults and high-risk populations1 Novavax's partners are ready to bring its protein-based, non-mRNA vaccine with a favorable tolerability profile to global markets, providing an important option for healthcare providers and patients Aug. 28, 2026 -- Novavax, Inc.'s (Nasdaq: NVAX) partners have received approvals for the Nuvaxovid™ formulation to target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in major ma

Spyre Therapeutics' stock was down about 14% Wednesday after a topline readout for one of its experimental TL1A antibodies underwhelmed in a Phase II rheumatoid arthritis (RA) study. While SPY072 showed activity, it failed to meet the company's internal efficacy bar for moving it forward as a stand-alone therapy. The candidate is being evaluated in the SKYWAY-RD basket trial across several rheumatic diseases, with separate sub-studies in RA, psoriatic arthritis (PsA) and axial spondyloarthritis

The RAS revolution is officially here, thanks to the FDA's approval of Rasonque (daraxonrasib) for adults with metastatic pancreatic ductal adenocarcinoma (PDAC) on Wednesday. Revolution Medicines' RAS inhibitor was greenlit less than five months after it first revealed "practice-changing" data suggesting the candidate could help patients live twice as long as standard chemotherapy (see – Spotlight On: Daraxonrasib set to revolutionise pancreatic cancer treatment landscape). "This drug showed u

Shanghai Minwei Biotechnology Co., Ltd. has registered a Phase I first-in-human clinical trial of MWN110, a monoclonal antibody targeting activin receptors ActRIIA and ActRIIB, in healthy volunteers and people with overweight or obesity. The study marks the first human trial of the asset, which Minwei, a subsidiary of Lepu Medical Technology (SHE: 300003), said was developed in-house and is covered by intellectual property rights held by the company. The study (NCT07779980) is a randomized, dou

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

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

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