Biohaven's NDA for Troriluzole was accepted by the FDA, potentially leading to approval in Q3 2025. Click here to find out ...

The FDA has granted priority review to brensocatib to treat patients with non-cystic fibrosis bronchiectasis, according to a ...

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 ...

A Prescription Drug User Fee Act target date of May 27, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application ...

BRIDGEWATER, N.J. - Insmed Incorporated (NASDAQ:INSM), a biopharmaceutical company with a market capitalization of $14.57 ...

The FDA has granted Priority Review status to the application and has set a target action date of August 12, 2025. The Priority Review designation is given to drugs that, if approved, would offer ...

Sunvozertinib received FDA priority review for NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy progression. The WU-KONG1 Part B study showed a 53.3% objective response ...

Insmed Incorporated INSM announced that the FDA has accepted its new drug application (“NDA”) seeking approval of its reversible inhibitor of dipeptidyl peptidase 1 (DPP1), brensocatib, for treating ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...

The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of 26 May 2025.

The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of July 22, 2025. The FDA also informed the Company that they are not currently planning to hold ...