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 ...

Another BCMA-targeted agent has arrived for the treatment of multiple myeloma. | After a delay, Regeneron’s BCMA-directed ...

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

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.

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

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

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 ...

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

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

As drug development increasingly targets multiple indications, pharma companies must make strategic branding ...