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The Contraceptive Study Group submits a second petition to FDA seeking changes in labeling for hormonally active contraceptives to...[ Price : $8.95]
FDA extends until 11/22 its review of a Savara BLA for molgramostim to treat autoimmune pulmonary alveolar proteinosis.[ Price : $8.95]
The Trump Administration looks to move FDA principal deputy commissioner Sarah Brenner to a senior leadership role at the CDC.[ Price : $8.95]
FDA issues an updated compliance program that standardizes how inspectors evaluate manufacturing facilities tied to biologic drug ...[ Price : $8.95]
CDER issues two revised Manuals of Policies and Procedures relating to developing and communicating postmarketing requirements and...[ Price : $8.95]
FDA plans a 7/23-24 Pharmacy Compounding Advisory Committee meeting to discuss adding certain peptides to the agencys bulk drugs f...[ Price : $8.95]
FDA cites significant manufacturing and data integrity deficiencies at Hikal Limited following a 2/2025 inspection of the companys...[ Price : $8.95]
FDA approves Travere Therapeutics Filspari (sparsentan), a therapy for treating patients with Focal Segmental Glomerulosclerosis.