The FDA has introduced Elsa, an internal AI tool to review safety data, identify labeling issues, and prioritize inspections, ...

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said ...

Pharmacoequity requires policies geared at equitable access to the right medicine for all individuals — regardless of race, ethnicity or socioeconomic status. This should be our north star.

FDA's plan to phase out animal testing may hurt Charles River's revenues. The DCF model suggests that CRL presents an ...

The Alzheimer’s Drugs Market is anticipated to experience a compound annual growth rate (CAGR) of approximately 20% over the ...

The U.S. Food and Drug Administration is revising the labeling of all extended-release attention-deficit/hyperactivity ...

Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...

Minovia Therapeutics said Monday that the Food and Drug Administration granted fast-track and rare-pediatric-disease designations to its lead investigational compound. The drug, MNV-201, is in Phase 2 ...

The FDA approved Zegfrovy for advanced non-small cell lung cancer with EGFR exon 20 mutations after chemotherapy.

Datroway received accelerated FDA approval for adults with EGFR+ advanced non-small cell lung cancer after EGFR-targeted and ...

It is the only ready-to-use liquid immunoglobulin therapy with (IgA) content and is set for commercialization in 2026.