A Friends of Cancer Research study update says FDA continues to review and approve novel cancer drugs faster than the European Medicines Agency.
Sanofi and Johnson & Johnson stop the development of their vaccine candidate for extraintestinal pathogenic E. coli because Phase 3 data show that it ...
The DC District Court rules for FDA in a Vanda Pharmaceuticals lawsuit seeking an agency order to revoke the approval of a Teva ANDA for a generic cop...
Travere Therapeutics says it will submit an sNDA to FDA for a new indication for its Filspari to treat focal segmental glomerulosclerosis.
FDA approves a Pfizer supplemental BLA for Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for treating certain adult pa...
FDA warns Healdsburg, CA-based ISOThrive about failing to submit an IND for two clinical trials it sponsored of an investigational drug.
FDA warns Chinas Wuhu Chemistry about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Olympus recalls its bronchoscope single-use guide sheath kits due to potential for the radiopaque tip of the sheath component to separate and fall off...
