The FDA has accepted for review the second resubmitted NDA for reproxalap for the treatment of the signs and symptoms of dry eye disease.

By Nicholas G. Miller Shares of ProKidney rose in early trading after it received FDA support for its path to accelerated approval of its rilparencel kidney disease drug.

ProKidney Corp. Announces FDA Alignment on Accelerated Approval Pathway for Rilparencel in Chronic Kidney Disease and Diabetes ...

Bayer AG BAYRY announced that the FDA has approved a label expansion of kidney disease drug Kerendia (finerenone). The regulatory body approved finerenone for the treatment of adult patients with ...

Regeneron Pharmaceuticals has received accelerated FDA approval for Lynozyfic, a new bispecific antibody treatment for adults with relapsed or refractory multiple myeloma who have undergone at ...

Bispecific antibodies are already available for treating multiple myeloma. FDA approval of Regeneron Pharmaceuticals’ new drug, Lynozyfic, comes with dosing flexibility that sets it apart from ...

FDA denies Unicycive's NDA for Oxylanthanum Carbonate due to vendor issues; company eyes quick resolution with alternate manufacturer in place.

The FDA has approved Gamifant as the first-ever treatment for macrophage activation syndrome in Still’s disease for adults and children who have an inadequate response or intolerance to ...

FDA approves new blood test used to detect early Alzheimer's disease ‘Absolutely Failed’: Senators Debate Presidential Authority Ukraine destroys Russian fighter-bombers in precision air base ...

The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid.