FDA grants Vera Therapeutics an accelerated approval for Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephr...
FDA sends Lundbeck Seattle Biopharmaceuticals an untitled letter alleging that promotional materials for its migraine therapy Vyepti (eptinezumab-jjmr...
Saol Therapeutics refiles its NDA for SL1009 (sodium dichloroacetate), an investigational treatment for pyruvate dehydrogenase complex deficiency, a r...
FDA releases the draft MDUFA performance goals and procedures approved by CDRH and CBER for the 2027 renewal of MDUFA that will cover FY 2028-2032.
FDA plans to publish a proposed rule by the end of the year that would require prescription drug advertisements on television, radio and similar broad...
Two Sheppard attorneys discuss an HHS Inspector General advisory opinion backing a drug companys arrangement with a third-party laboratory for free an...
During a CBS News interview, former CDC chief medical officer Debra Houry says she left the agency after concluding she could no longer defend its sci...
FDA briefing materials show that agency reviewers have found limited evidence supporting the safety and effectiveness of seven peptide substances that...
