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Regeneron says it will submit an application to FDA by the end of 2025 seeking approval for its garetosmab to treat adults with fi...[ Price : $8.95]
Three Sidley attorneys suggest ways drug companies can take advantage of the flexibility in FDAs guidance on using alternative too...[ Price : $8.95]
FDA issues an alert after becoming aware that Abbott issued a letter to customers recommending updated instructions when removing ...[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at Wichita, KS-based Fagron Compounding Services.[ Price : $8.95]
FDA approves Biocon Biologics biosimilars for Amgens Prolia and Xgeva.[ Price : $8.95]
FDA issues a draft guidance revising and updating a 2013 guidance on safety labeling changes when new safety information becomes a...[ Price : $8.95]
The House Energy and Commerce Committee unanimously approves legislation to reauthorize FDAs Rare Pediatric Disease Priority Revie...[ Price : $8.95]
FDA approves an AstraZeneca supplemental NDA for Airsupra (albuterol/budesonide) to expand the drugs labeling to reflect a 46% red...