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...

REGN gets FDA nod for Dupixent for a broader population for the indication of chronic rhinosinusitis with nasal polyps.

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.

HORSHAM, Pa. (September 11, 2024) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved...