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20 earlier
FDA issues Emergency Use Authorization (EUA) for Bimectin (ivermectin) injection for the prevention of New World screwworm (NWS) infestations (myiasis) in cattle when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound.
Original title: “FDA Issues Emergency Use Authorization for Generic Drug to Prevent New World Screwworm in Cattle”
Tezspire succeeded in a study in eosinophilic esophagitis, which could become the drug’s third approved indication and unlock what’s viewed as a blockbuster opportunity.
Original title: “New data could widen use of AstraZeneca, Amgen immune disease drug”
AstraZeneca and Amgen co-develop and co-commercialize Tezspire under an April 2012 agreement. The partners are now planning another FDA submission for the asthma drug, which received an expansion into chronic rhinosinusitis last year.
Original title: “AstraZeneca, Amgen notch another late-stage win for Tezspire, this time in esophagitis”
Designation supports rapid development of pan‑RAS molecular glue
Original title: “Erasca secures FDA fast track for eras‑0015 in pancreatic cancer”
New device classification created for precision optical filter
Original title: “Avulux gains FDA authorisation for migraine light‑sensitivity lens”
Rasonque’s speedy approval — just a month after a completed submission — represents a paradigm shift for a notoriously deadly cancer and begins what analysts see as a highly lucrative drug launch.
Original title: “Revolution drug heralded as a pancreatic cancer breakthrough cleared by FDA”
In a key clinical trial, patients who got the pill, daraxonrasib, lived twice as long as those who got chemotherapy. It is not a cure, but it is the first treatment to substantially extend the lives of patients with pancreatic cancer. The drug, daraxonrasib, is made by Revolution Medicines and will be sold under the brand name Rasonque. It was approved for patients who have metastatic pancreatic cancer and have already tried chemotherapy. In a key clinical trial, participants who got daraxonrasib lived for a median of over 13 months, compared with less than seven months for those who got chemotherapy. Some patients who have gotten the drug through clinical trials have lived for years. Since May, more than 2,000 patients have received free, early access to the drug through an expanded access program that the company set up after its key clinical trial concluded. The Food and Drug Administration approved on Wednesday a new drug for advanced pancreatic cancer, ushering in a new era of treatment for a disease that has long been considered one of the most hopeless in medicine.
Original title: “F.D.A. Approves the Drug Daraxonrasib That’s Poised to Transform Pancreatic Cancer - The New York Times”
GV101, a novel, highly selective ROCK2 inhibitor, yielded an 86.2% best overall response rate (bORR) at 400 mg and a 67.9% bORR at 200 mg at 24 weeks in... GV101, a novel, highly selective ROCK2 inhibitor, yielded an 86.2% best overall response rate (bORR) at 400 mg and a 67.9% bORR at 200 mg at 24 weeks in chronic Graft versus Host Disease (cGvHD) patients who had failed at least two prior lines of therapy. Despite advances in treatment, many patients experience inadequate responses, disease recurrence, and intolerable AEs. There is significant unmet need for an effective early-stage therapy that targets the key drivers of cGvHD, fibrosis and immune dysregulation, whilst preserving immune function. ... GV101 is a clinical-stage, best-in-class selective inhibitor of Rho/Rho-associated coiled-coil containing protein kinase 2 (ROCK2). 26, 2026 /PRNewswire/ -- Graviton BioScience Corporation, a privately held, clinical-stage biotechnology company, announced the publication of peer-reviewed data from a multicenter Phase Ib/II multi-dose, open-label clinical trial evaluating the safety, tolerability, and efficacy of GV101 in patients with moderate to severe chronic Graft versus Host Disease (cGvHD). The data, published in Signal Transduction and Targeted Therapy, a Springer Nature Portfolio journal, provide efficacy and findings from the 60 enrolled patients, 30 at 200 mg and 30 at 400 mg, who had previously received one to five prior systemic therapies for cGvHD. Graviton BioScience Corporation is a clinical-stage drug discovery and development company dedicated to engineering and developing best-in-class therapeutics for treating metabolic, CNS, inflammatory, fibrotic, and other disease indications. Graviton has developed a portfolio of selective ROCK2 inhibitors among other safe, innovative, and novel therapies for patients with fibrotic, autoimmune, and CNS diseases.
Original title: “Graviton BioScience Corporation Announces Publication of Positive Ph1b Trial Results for GV101 (TDI01) in Chronic Graft versus Host Disease in Signal Transduction and Targeted Therapy, by Beijing Tide Pharmaceutical”