Aztron Medtech wins a Taiwan Presidential Award as TendMIN passes 200 U.S. procedures and the company prepares its next financing round.
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
Mezzion reports animal-model ADPKD data for udenafil as it prepares Phase 2b testing. The findings support development, but human efficacy is unproven.
Huonslab’s HyDIFFUZE patent targets subcutaneous ADC formulations, but preclinical evidence and clinical translation remain the real test.
Glaukos completes PRESERFLO pivotal enrollment, shifting focus to 12-month data, FDA clearance and advanced glaucoma adoption.
Kelun-Biotech’s SKB565 gains China clinical trial clearance, moving its first dual-payload ADC toward a Phase 1/2 solid-tumor study.
Harbour BioMed and Sinopharm form a biologics R&D consortium spanning antibody discovery, clinical development, manufacturing and commercialisation.
Otsuka’s SIMTRIYO wins FDA approval for ADHD, but DEA scheduling, boxed warnings and payer access will shape its commercial uptake.
ArkBio has dosed all Phase I cohorts of AK0406, moving the long-acting influenza prophylaxis candidate into six-month safety follow-up.
JCR Pharmaceuticals’ UAE authorization for IZCARGO opens a new market, but reimbursement, supply and Phase III evidence will shape its impact.