Proceeds from transaction to support advancement of Denali’s broad TransportVehicle™-enabled clinical portfolio for lysosomal storage disorders ...

Denali Therapeutics Inc. DNLI announced that it has entered into a definitive agreement to sell its Rare Pediatric Disease ...

The FDA is anticipated to make its decision on the regimen by 9 October 2026.

A regulatory decision on the application is expected during the fourth quarter of 2024. The Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License ...

Priority review recognizes the serious nature of epidermolysis bullosa (EB) and the urgent need for continued evaluation of ...

A Prescription Drug User Fee Act target date of November 30, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application ...

The US Food and Drug Administration (FDA) is set to increase the fee it charges users of a special, transferable voucher meant to reward developers of tropical disease treatments with an expedited ...

A research letter published in JAMA Internal Medicine this week finds that class III medical devices that receive expedited reviews are more likely to be recalled, and after spending less time on the ...

Priority review for ravulizumab in IgA nephropathy could establish the first C5 complement inhibitor label in this indication, addressing substantial residual progression risk despite current standard ...

Bayer recently announced that the U.S. FDA has granted Priority Review to HYRNUO (sevabertinib) as a first-line treatment for adults with locally advanced or metastatic HER2-mutated non-small cell ...

The FDA granted Welireg a priority review after it showed promising outcomes for patients with pretreated advanced renal cell carcinoma. The Food and Drug Administration (FDA) granted a priority ...