The timeline extension comes on the heels of the FDA requesting additional information to assess Filspari’s clinical benefit.

By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it ...

The FDA has issued a complete response letter for the partners’ application in EBV+PTLD, marking the agency’s second snub of ...

In an interview with Bloomberg News, Eli Lilly Chief Financial Officer Lucas Montarce said that the Indiana-based pharma ...

MoonLake regains momentum after the FDA Type B meeting allows BLA submission for sonelokimab in HS without additional trials.

On track to define optimal dosing interval and advance manufacturing scale up of REYOBIQ for pivotal trial readiness in late ...

The FDA issued a CRL for ONS-5010, citing the need for additional confirmatory efficacy evidence despite previous trials ...

Larimar Therapeutics, Inc. has announced a refined timeline for submitting a Biologics License Application (BLA) for its treatment nomlabofusp, aimed at addressing Friedreich's Ataxia (FA). Based on ...

The FDAAA did not significantly alter the overall time to first postmarket safety action for novel therapeutics. Earlier safety actions were observed within the first five years post-approval, ...

The U.S. Food and Drug Administration on Thursday introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare ...

Senate Republicans, who voted unanimously in support of Makary’s confirmation in March, have expressed mistrust following the covert announcement of the approved application for telehealth provider ...