The Food and Drug Administration announced the launch of a new program to fast-track agency approvals for drug manufacturers ...

WASHINGTON (AP) — U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as ...

The BLA was supported by the Phase III VISIONARY trial data. GlobalData believes that sibeprenlimab’s latest priority review further signifies the drug’s major advantages over existing ...

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgAN ...

Against the stark backdrop of the FDA job cuts, stakeholders in the rare disease space find themselves facing heightened uncertainty. In late March 2025, the Trump administration moved forward ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for finerenone for the treatment of adult patients with heart failure (HF ...

I'm happy to report that not only did it complete the rolling BLA submission of Deramiocel, but the FDA accepted the regulatory application with Priority Review with a PDUFA target action date of ...

Priority review reduces the BLA review timeline to 6-months and is granted to therapies that, if approved, would provide significant improvements in the treatment, diagnosis or prevention of ...

Zongertinib is under FDA priority review for HER2-mutant advanced NSCLC, showing promise as a groundbreaking oral therapy. The phase 1b BEAMION LUNG-1 trial reported a 71% objective response rate and ...

Dupilumab has been accepted for priority review by the US Food and Drug Administration (FDA) for the treatment of bullous pemphigoid (BP) in adults, according to a press release from the ...

Gilead Sciences has won Food and Drug Administration priority review for its proposed lenacapavir twice-yearly shot to prevent HIV. Gilead on Tuesday said an FDA green light would make lenacapavir ...

Brensocatib, Insmed's lead pipeline candidate for non-CF bronchiectasis, received FDA Priority Review with a target action date of August 12, 2025. This is a potential multi-billion dollar selling ...