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Regulatory Approval

Clinical Research FDA Submissions Clinical Trials Clinical Studies Anvisa European Medicines Agency New Antibiotics Biologics License Application Accelerated Approval FDA Processes Clinical Efficacy FDA Priority Review FDA Clinical Use Eli Lilly's Retatrutide FDA Approval Marketing Authorisation AstraZeneca

8 ARTICLES

2w ago

AstraZeneca's Tozorakimab Cuts COPD Flare‑Ups in Two Phase 3 Trials

The drug showed broad benefit and a placebo‑like safety profile and now faces an expedited U.S. review with a PDUFA target in the first quarter of 2027.

6 ARTICLES

last mo.

AbCellera’s Menopause Antibody Hits Phase 2 Goals

3 ARTICLES

2mo ago

EU Regulators Back AstraZeneca’s Trixeo for Asthma

6 ARTICLES

10mo ago

Sorfequiline Outperforms Standard TB Regimens in Phase 2 Trial