The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up ...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema following ...

After 3 initial monthly injections, current dosing intervals range from every 8 to 16 weeks in patients with wAMD and DME and every 8 to 12 weeks in patients with DR.

The complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said.

The FDA issued a complete response letter for a supplemental biologics license application, in which it did not approve ...

The top 20 biopharmas demonstrated a strong start to 2025, despite ongoing uncertainty surrounding Trump’s tariffs.

Regeneron signs $3 billion deal with FUJIFILM to expand biologics manufacturing in North Carolina, boosting U.S. capacity and ...

Besides Wall Street's top -and-bottom-line estimates for Regeneron (REGN), review projections for some of its key metrics to gain a deeper understanding of how the company might have fared during the ...

This was a low-key week for the biotech sector before the onset of the first-quarter earnings season. Biotech giant Bristol Myers Squibb BMY was down on data from the schizophrenia study while ...

Two people in Oregon have died and a third person has a confirmed case of the mad cow-like brain disease Creutzfeldt-Jakob ...