The U.S. Food and Drug Administration (FDA) has approved Pasatru (garetosmab-grts) to reduce new heterotopic ossification (bone formation outside the skeleton) and reduce clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). Pasatru is the second drug approved for patients with this very rare disease.
U.S. Food and Drug Administration published the draft guidance for industry titled “Determining Whether to Submit an ANDA or 505(b)(2) Application.” This guidance assists applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) described in sections 505(j) and 505(b)(2) is appropriate for the submission of a …
FDA is launching the Drug Supply Chain Security Act (DSCSA) Assessment of Small Dispensers. This assessment is designed to evaluate small dispensers’ ability to conduct interoperable tracing of product at the package level.
EMA’s Head of the Stakeholders and Communication Division Melanie Carr has been assigned Deputy Executive Director duties as of 1 August 2026. Since 2021, this role has been held by Ivo Claassen, Head of the Veterinary Medicines DiEMA’s Head of the Stakeholders and Communication Division Melanie Carr has been assigned Deputy Executive Director duties as …
On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
FDA Center for Drug Evaluation and Research (CDER), in partnership with the CDER Quantitative Medicine Center of Excellence, announced a request for information regarding a new collaborative ecosystem for quantitative medicine: the Quantitative Medicine Innovation Network (QMIN).
