In light of the significant drop in Regeneron’s stock price, a natural question emerges: is REGN now a viable buying ...

Additionally, regulatory hurdles, such as the Complete Response Letter (CRL) received for the Eylea HD pre-filled syringe, have created obstacles for the company’s near-term growth plans. However, ...

Additionally, regulatory hurdles, such as the Complete Response Letter (CRL) received for the Eylea HD pre-filled syringe, have created obstacles for the company’s near-term growth plans.

Samsung Biologics Co., the world’s largest contract drugmaker, will undergo a strategic split to separate its contract development and manufacturing orga ...

Biotech company Regeneron (NASDAQ:REGN) in Q1 CY2025, with sales falling 3.7% year on year to $3.03 billion. Its non-GAAP ...

a complete response letter in the US for Eylea HD's prefilled syringe, and a funding gap at Good Days, a large copay assistance organization that supports US eye drug sales. On the bright side ...

The target action date is August 19, 2025. However, the regulatory body issued a complete response letter (CRL) for the Eylea HD pre-filled syringe. The CRL was mostly issued due to a third-party ...

The FDA issued a Complete Response Letter (CRL) for the EYLEA HD pre-filled syringe on April 23, 2025. The Company held several teleconferences with the FDA to better understand the contents of ...

Regeneron has been looking to switch patients to a higher-dose version of the drug, branded as Eylea HD, to stymie the loss in market share to cheaper versions and rivals. The U.S. Food and Drug ...

The U.S. Food and Drug Administration declined to approve a pre-filled syringe version of Eylea HD last week citing issues with a third-party supplier. The FDA has committed to a speedy review of ...

Another complete response letter from the U.S. FDA for Regeneron Pharmaceuticals Inc.’s age-related macular degeneration (AMD) therapy Eylea (aflibercept) – along with disappointing sales of the VEGF ...