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FDA clarifies its enforcement discretion timeframes for compounded tirzepatide.[ Price : $8.95]
FDA approves a Genentech NDA for a new tablet formulation of Evrysdi (risdiplam) for treating people with spinal muscular atrophy.[ Price : $8.95]
Travere Therapeutics says it will submit an sNDA to FDA for a new indication for its Filspari to treat focal segmental glomerulosc...[ Price : $8.95]
FDA approves a Pfizer supplemental BLA for Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for treat...[ Price : $8.95]
FDA warns Healdsburg, CA-based ISOThrive about failing to submit an IND for two clinical trials it sponsored of an investigational...[ Price : $8.95]
FDA warns Chinas Wuhu Chemistry about CGMP deviations in its manufacturing of active pharmaceutical ingredients.[ Price : $8.95]
Olympus recalls its bronchoscope single-use guide sheath kits due to potential for the radiopaque tip of the sheath component to s...[ Price : $8.95]
AnaptysBio reports positive data from a Phase 2 study of rosnilimab for treating moderate-to-severe rheumatoid arthritis.