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...
Endo Health Solutions agrees to plead guilty in federal court and pay over $2 billion in penalties to resolve criminal and civil investigations relate...
FDA declines to grant a hearing request by Vanda Pharmaceuticals on a stalled supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder...
