Novo Nordisk secures EMA approval for Rybelsus label update
Novo Nordisk has received the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) approval for the…
16 Sep 2025
aTyr Pharma stock crashes on Phase III pulmonary sarcoidosis fail
aTyr Pharma shares plunged more than 80% after its Phase III trial in pulmonary sarcoidosis failed to meet its primary endpoint. In the EFZO-FIT study (NCT05415137), efzofitimod failed to show…
16 Sep 2025
Cadrenal Therapeutics acquires eXIthera’s Factor XIa inhibitors
Cadrenal Therapeutics has acquired eXIthera Pharmaceuticals’ portfolio of Factor XIa inhibitors to expand its offerings in the anticoagulation market. Under the deal, eXIthera will receive up to $15m in milestone…
15 Sep 2025
Novartis returns to Monte Rosa for second time in a year with $5.7bn deal
Novartis has ventured back to Monte Rosa Therapeutics tasked with finding more immune-mediated disease drug candidates, signing a licensing deal worth up to $5.7bn. The agreement will see Novartis pay…
15 Sep 2025
AstraZeneca halts £200m research investment in Cambridge
AstraZeneca has halted its planned £200m ($270m) investment in a research facility in Cambridge, UK, according to reports from Reuters. The investment, which was anticipated to generate 1,000 new jobs,…
15 Sep 2025
FDA chief blames decades of regulatory failure for misleading pharma ads
The US Food and Drug Administration (FDA) commissioner Martin Makary has described the current state of direct-to-consumer pharmaceutical advertising as a “public health crisis” in the US, citing lax regulatory…
15 Sep 2025
Amneal secures FDA approval for sodium oxybate solution
US-based Amneal Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its 500mg/mL sodium oxybate oral solution. The solution is prescribed for managing cataplexy and excessive…