Why Asymchem’s first FDA inspection at Dunhua 2 matters far beyond one carbapenem API
Asymchem’s Dunhua 2 site completes its first FDA inspection, advancing continuous carbapenem API manufacturing and U.S. supply readiness.
Pharma & Biotech
Medical Devices & Diagnostics
Can Elephas move beyond immunotherapy? New elive data opens a targeted therapy pathway
Elephas reports early elive data showing cytotoxicity measurement with daraxonrasib, expanding live tumor profiling beyond immunotherapy.
Medical Devices & Diagnostics
Can vitamin E polyethylene reduce reverse shoulder wear? Advita Ortho starts first clinical cases
Advita Ortho begins clinical use of Activit-E Equinoxe liners, testing whether advanced polyethylene can improve reverse shoulder durability.
Medical Devices & Diagnostics
How NanoCellect technology strengthens Nova Biomedical’s cell line development strategy
Nova Biomedical adds NanoCellect cell sorting technology to connect single-cell isolation, clonality verification and bioprocess analytics.
Pharma & Biotech
NewAmsterdam Pharma and Menarini receive positive CHMP opinion for Ubeslo and Evlarco
CHMP backs Ubeslo and Evlarco, moving obicetrapib closer to European authorization while PREVAIL tests cardiovascular outcomes.
Pharma & Biotech
Estrella’s EB103 kept early lymphoma remissions intact, but one trial detail still needs explaining
Estrella advances EB103 into STARLIGHT-1 expansion as early lymphoma remissions endure, while trial scale, safety and funding remain key tests.
Pharma & Biotech
Organon VTAMA analysis shows consistent atopic dermatitis efficacy across children and adults
Organon’s VTAMA Phase 3 analysis shows consistent atopic dermatitis responses across children and adults, strengthening its clinical case.
Pharma & Biotech
Why Enhertu’s EU recommendation could end a decade of stability in first-line HER2 breast cancer treatment
EU regulators back Enhertu plus pertuzumab for first-line HER2-positive metastatic breast cancer, shifting focus to approval, safety and access.
Pharma & Biotech
Kenvue wins FDA approval for first OTC acetaminophen and naproxen sodium combination
FDA approval gives Kenvue a 12-hour Tylenol and naproxen product, but safety warnings and retail execution will shape its commercial impact.
Pharma & Biotech
Why American Regent’s single-lot papaverine recall carries a potentially serious injectable safety risk
American Regent recalls one papaverine injection lot after glass or paraformaldehyde particles were found, raising serious injectable safety concerns.