Sen. Tim Scott and Rep. Earl Carter say a recent FDA guidance on advanced manufacturing technologies for drugs does not match congressional intent in ...
Federal Register notice: FDA amends its standing advisory committee regulations to add the 12/13/2023 establishment of the Genetic Metabolic Diseases ...
FDA extends by three months its review on a Zevra Therapeutics NDA resubmission for arimoclomol, an investigational oral treatment for Niemann-Pick di...
FDA approves Hugels Letybo (botulinum toxin), a neurotoxin for treating moderate-to-severe glabellar (frown) lines in adults.
Federal Register notice: FDA announces a 5/16 Vaccines and Related Biological Products Advisory Committee meeting to discuss the strains to be include...
FDA removes a partial clinical hold on Iovance Biotherapeutics IOV-LUN-202 trial investigating the companys LN-145 TIL cell therapy in non-small cell ...
SpringWorks Therapeutics commences a rolling NDA for mirdametinib, an investigational MEK inhibitor for treating pediatric and adult patients with neu...
CBER cites Oregon Medical Centers in an untitled letter over claims it is making on social media sites Facebook and Youtube about its cellular product...
