1,873 Results
FDA approves leniolisib for APDS in children aged 4–11, using PK bridging from an 8-patient study to extend the 2023 adult approval.
Lonza's new Bend, Oregon spray-drying facility targets commercial-scale SDD manufacturing, addressing a persistent CDMO capacity gap for poorly soluble compounds.
NMPA accepts Nicox's NCX 470 NDA for review, with a regulatory decision expected within 12–18 months of the August 2026 submission.
Axcelead presents salivary biomarker data as a rodent surrogate for GLP-1-related nausea at the 2026 JSSO/JSTO joint meeting.
XORTX begins GMP manufacturing of XORLO™, structuring CMO batches to supply XRX-OXY-102 and build NDA validation data concurrently.
FDA, NIH, and CDC workshop maps regulatory and manufacturing gaps for Valley fever vaccines, with implications for biologics developers and CMOs.
Medical Action Industries issues Class I correction for epidural kits after Huons sterility failure cascades through Spectra Medical Devices to kit level.