STAT2d
FDA’s new guidance on AI in drug development centers the risk introduced by the technology
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
Rigel Pharmaceuticals Gets FDA Orphan-Drug Designation for R289
Rigel Pharmaceuticals on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to its proposed R289 treatment for myelodysplastic syndromes, a group of rare blood cancers ...
FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo
The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's ...
PureTech Drug Gets FDA Fast-Track Designation for Leukemia
The biotherapeutics company said the treatment, LYT-200, is being evaluated in two ongoing clinical trials. It was previously granted orphan drug designation for the treatment of acute myeloid ...
Health Affairs2d
What Makes A Drug Special?: Understanding PBMs’ Pharmacy Definitions
With multiple stakeholders involved with different interests, the “specialty drug” definition can be a moving target.
Astellas Pharma’s Resubmission for IZERVAY Accepted by FDA
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