FDA extended review dates for Eylea HD submissions to Q4 2025 due to third-party manufacturing inspection findings. The extension includes a CMC Prior-Approval Supplement for a prefilled syringe and ...

TARRYTOWN, N.Y., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates to the ...

TARRYTOWN, N.Y., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates ...

TARRYTOWN, N.Y., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates ...

Mural Oncology will be acquired by XRA 5 Corp. for $2.035 per share, with potential additional payments, totaling approximately $36.2 million. The acquisition is part of XOMA's strategy to expand its ...

This article reviews the safety, efficacy, and regulatory concerns related to compounded semaglutide, with a focus on how health care providers can offer guidance and education to patients.

Ozempic is approved by the Food and Drug Administration (FDA) for certain uses in people with type 2 diabetes. It can be prescribed off-label to help with weight loss, but it’s not approved for this ...

IL Group, a specialist in multifunctional labeling solutions for the pharmaceuticals and healthcare sectors, played a critical role in helping Exela Pharma Sciences - a U.S.-based specialty ...

Rafael Sepulveda Acosta, M.D. Sleep Medicine / Obesity Medicine / Internal Medicine Dr. Rafael Sepulveda Acosta is a board-certified physician with experience in internal medicine, pediatric and adult ...