The U.S. Food and Drug Administration (FDA) announced its intent to expand the use of unannounced inspections at foreign ...

C-Path quickly emerged as a pioneer in accelerating drug development by launching landmark consortia and earning early regulatory endorsements for innovative safety kidney biomarkers by FDA ...

A vocal opponent of his predecessor Peter Marks, Vinay Prasad will now lead the office tasked with reviewing some genetic ...

Mineralys Therapeutics reports strong Q1 2025 results, announcing pivotal trial success for lorundrostat, a $201M equity raise, and progress toward ...

Sangamo Therapeutics Inc (SGMO) secures a major deal with Eli Lilly and advances its pipeline, while navigating funding needs ...

Recently, underscoring a commitment to national security, the White House and the Food and Drug Administration (FDA) issued separate ...

However, there is a catch, and it could be a big one when the drug comes in front of regulatory reviewers ... and it remains to be seen whether the FDA will be swayed the LUCIDITY data without ...

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) ("Adial” or the "Company”), a clinical-stage biopharmaceutical company focused on ...

Q1 2025 Earnings Call Transcript May 12, 2025 FibroGen, Inc. misses on earnings expectations. Reported EPS is $-0.16 EPS, ...

Topline efficacy and safety data for Phase 2b extension maintenance study expected in the second quarter of calendar 2025 -- --With positive Phase 2b QUALITY study, Veru plans for end of Phase 2 ...