DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS...

DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS...

The approval expands the label of TVTX's Filspari in IgAN indication. However, the label also comes with a boxed warning for liver problems and...

The approval expands the label of TVTX's Filspari in IgAN indication. However, the label also comes with a boxed warning for liver problems and...

The Johnson & Johnson filing seeks the FDA's approval for nipocalimab to treat generalized myasthenia gravis in a broad population of...

KalVista announces FDA acceptance of New Drug Application for sebetralstat for oral on-demand treatment of hereditary angioedema KalVista...

Providers of vaccines against African swine fever (ASF) from four countries are seeking the Food and Drug Administration’s (FDA) approval, according...

Providers of vaccines against African swine fever (ASF) from four countries are seeking the Food and Drug Administration’s (FDA) approval, according...

The FDA accepts Axsome's resubmission of the NDA for AXS-07 for the acute treatment of migraine. A decision is due on Jan. 31, 2025. Shares rise.

The Food and Drug Administration (FDA), as many are aware, is the leading entity for the regulation and safety testing for foods and pharmaceuticals...