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

Gossamer Bio has announced a private placement agreement valued at up to $250m, including $150m of committed capital intended to support the development and potential US Food and Drug Administration (FDA) approval of seralutinib. Seralutinib is intended for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The private investment comprises an initial closing, a subsequent closing contingent upon FDA acceptance o

Charles River Laboratories (CRL) and Taiwan-based Medigen Vaccine Biologics are teaming up to prep Medigen’s multivalent enterovirus vaccine for global expansion. The collaboration is designed to characterize and validate the virus seed bank for Medigen’s vaccine and will leverage CRL’s analytical platforms, according to a Thursday release . CRL’s Next-Generation Sequencing will support the chemistry, manufacturing and controls steps to advance the vaccine program, including Medigen’s Envacgen

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