AstraZeneca gets CRL for prefilled pen version of lupus drug Saphnelo

Anna Brown / endpoints - The FDA has handed AstraZeneca a complete response letter for the subcutaneous prefilled, self-injectable pen of Saphnelo for systemic lupus erythematosus (SLE), a month after the asset gained approval in Europe ...

AI Summary: AstraZeneca’s application to market its subcutaneous prefilled pen formulation of Saphnelo for treating lupus has hit a roadblock after the FDA issued a complete response letter. The decision delays the drug’s approval and raises questions about its future in the competitive immunotherapy market.

#healthcare #pharmaceuticals #biotech #drugdevelopment #fda

Former AstraZeneca senior staff charged with illegal trade in China

3 months / endpoints / Nicole DeFeudis

Moderna says FDA refuses its application for new mRNA flu vaccine

3 months / medicalxpress

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

3 months / oncodaily

FDA delays approval of AstraZeneca’s injectable lupus drug

3 months / beckershospitalreview / Ella Jeffries

AstraZeneca gets CRL for prefilled pen version of lupus drug Saphnelo

3 months / endpoints / Anna Brown

StackHealth RSS

You can now follow topics by RSS - browse the complete list of topics, people, and organizations. Or, try Price Transparency, Eli Lilly, Wildlife, Pancreatic Cancer and look for the RSS link.

StackHealth Time Machine

More StackHealth