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news.EC grants marketing authorisation for IntraBio’s Aqneursa
The decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Aqneursa is approved across the EU
The decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Aqneursa is approved across the EU
This partnership provides the biopharmaceutical company with early access to the Chai-3 model alongside a dedicated model tailored to Pfizer’s proprietary data and workflows, underscoring a strategic move
This advance recognises preliminary data indicating that salanersen may show substantial improvement over existing therapies for SMA. The FDA’s decision follows data from a Phase Ib study on
The collaboration aims to conduct a full technical and operational assessment of Cellares’ automated manufacturing and testing platforms. This is in preparation for the anticipated demand surrounding TSC-101
The collaboration combines CytomX’s Probody technology with Regeneron’s Veloci‑Bi bispecific platform to target hard‑to‑treat tumour types. Established in 2022, the partnership combines CytomX’s biologic masking technology with Regeneron’s
This marks the second indication for Aquipta in the EU, where it is now approved both for acute attacks and as a once-daily preventive treatment for adults experiencing
The application seeks approval of giredestrant as an adjuvant treatment for adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I to III breast
The regulator granted the application priority review for this indication, assigning a Prescription Drug User Fee Act (PDUFA) date of 30 September 2026. Camzyos is currently approved for
The value includes a $1.55bn upfront payment and as much as $1.1bn in regulatory and commercial milestone payments. The acquisition aligns with Servier’s strategic goal in rare neurology,
The agreement covers Hanmi’s candidate that uses its LAPSCOVERY long-acting platform technology. Sonefpeglutide combines Hanmi’s proprietary technology and has previously achieved approval from the US Food and Drug