Olorofim Phase 3 results show fewer kidney complications in patients with invasive aspergillosis
F2G and Shionogi's oral olorofim meets Phase 3 aspergillosis endpoint with fewer kidney adverse events. Explore the results and FDA plans.
Pharma & Biotech
Medical Devices & Diagnostics
Aztron Medtech just doubled TendMIN’s U.S. procedure count. Can the next financing round turn early adoption into scale?
Aztron Medtech wins a Taiwan Presidential Award as TendMIN passes 200 U.S. procedures and the company prepares its next financing round.
Pharma & Biotech
FDA clears Shanghai Ark Biopharmaceutical’s ziresovir Phase 2 trial in critically ill infants with RSV
Shanghai Ark Biopharmaceutical Co., Ltd. ((ArkBio) has received authorization from the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 trial of ziresovir, an oral antiviral being developed for infants with severe respiratory syncytial virus infection, including patients requiring treatment in a pediatric intensive care unit. The planned multicenter, randomized, double-blind and placebo-controlled
Pharma & Biotech
Mezzion’s new kidney disease data sent shares higher, but the decisive test is still ahead
Mezzion reports animal-model ADPKD data for udenafil as it prepares Phase 2b testing. The findings support development, but human efficacy is unproven.
Pharma & Biotech
Can Huonslab crack oncology’s next drug-delivery problem? New patent targets injectable ADCs
Huonslab’s HyDIFFUZE patent targets subcutaneous ADC formulations, but preclinical evidence and clinical translation remain the real test.
Medical Devices & Diagnostics
Glaukos has enrolled the PRESERFLO pivotal study, but the decisive U.S. evidence is still ahead
Glaukos completes PRESERFLO pivotal enrollment, shifting focus to 12-month data, FDA clearance and advanced glaucoma adoption.
Pharma & Biotech
SKB565 clinical trial: Why Kelun-Biotech’s first dual-payload ADC matters
Kelun-Biotech’s SKB565 gains China clinical trial clearance, moving its first dual-payload ADC toward a Phase 1/2 solid-tumor study.
Pharma & Biotech
Harbour BioMed’s Sinopharm alliance spans the entire drug lifecycle, but its first real test has not been named
Harbour BioMed and Sinopharm form a biologics R&D consortium spanning antibody discovery, clinical development, manufacturing and commercialisation.
Pharma & Biotech
Otsuka’s SIMTRIYO has FDA approval, but two hurdles will decide whether it can disrupt ADHD care
Otsuka’s SIMTRIYO wins FDA approval for ADHD, but DEA scheduling, boxed warnings and payer access will shape its commercial uptake.
Pharma & Biotech
What does ArkBio’s AK0406 dosing milestone mean for long-acting influenza prevention?
ArkBio has dosed all Phase I cohorts of AK0406, moving the long-acting influenza prophylaxis candidate into six-month safety follow-up.