Nucala (mepolizumab) for severe asthma also held up well despite the launch of rival therapies from Sanofi/Regeneron and AstraZeneca ... get a lift from a new auto-injector formulation that ...

The other unusual part of Vertex's story is that is still not making a profit – a demonstration that rare disease R&D isn't always an automatic ... that for a daily injection over 12 months ...

The FDA approved dihydroergotamine (DHE) mesylate injection (Brekiya) to treat acute migraine (with or without aura) and ...

TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals ... for EYLEA HD ® (aflibercept) Injection 8 mg across all approved indications. The CRL did not identify any ...

“Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation EYLEA HD® (aflibercept) Injection 8 mg; uncertainty of the ...

Injection 8 mg; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products (such as EYLEA HD) and Regeneron's Product Candidates and the impact of the ...

"Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation EYLEA HD ® (aflibercept) Injection 8 mg; uncertainty of the utilization ...

(RTTNews) - Regeneron Pharmaceuticals ... the supplemental Biologics License Application for EYLEA HD (aflibercept) Injection 8 mg for the treatment of retinal vein occlusion.

Injection 8 mg across all approved indications. The CRL did not identify any issues with the safety or efficacy of EYLEA HD in its approved indications and dosing regimens. The FDA did not agree with ...