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Media Kit
FDA Approval (3)
284 Articles Available
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FDA Approval
FDA Approves Bayer's Nubeqa® (darolutamide) for Prostate Cancer
PR-M08-19-NI-001
Drug Risk
FDA Approves Boxed Warning About Increased Risk of Blood Clots and Death with Higher Dose of Xeljanz
PR-M07-19-NI-074
FDA Approval
FDA Approves First Treatment for Severe Hypoglycemia that can be Administered Without an Injection
PR-M07-19-NI-072
Biosimilar
FDA Approves Samsung Bioepis' HADLIMA™ (adalimumab-bwwd)
FDA Approval
FDA Approves OTEZLA® (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease
PR-M07-19-NI-068
Generics
FDA Approves First Generics of Lyrica
PR-M07-19-NI-060
FDA Approval
MSN Labs/Novadoz Pharmaceuticals Early Success Continues With FDA Approval Of Generic Abiraterone
PR-M07-19-NI-045
FDA Approval
FDA Approves Bayer's Gadavist® (gadobutrol) Injection as the First and Only Contrast Agent for Use in Cardiac MR for Coronary Artery Disease
PR-M07-19-NI-040
FDA Approval
FDA Grants Additional Myeloma Approval to J&J’s Darzalex
PAO-M07-19-NI-014
FDA Approval
Grifols Announces FDA Approval of Xembify®, 20% Subcutaneous Immunoglobulin for Primary Immunodeficiencies
PR-M07-19-NI-018
FDA Approval
Pfizer Receives U.S. FDA Approval for Its Oncology Biosimilar, ZIRABEV™ (bevacizumab-bvzr)
PR-M07-19-NI-015
FDA Approval
Dova Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for DOPTELET® (avatrombopag) for Treatment of Chronic Immune Thrombocytopenia (ITP)
PR-M07-19-NI-005
FDA Approval
FDA Approves First Treatment for Chronic Rhinosinusitis with Nasal Polyps
PR-M07-19-NI-003
Drug Approval
FDA Expands Approval of Treatment for Cystic Fibrosis to Include Patients Ages 6 and Older
PR-M06-19-NI-056
FDA Approval
FDA Approves New Treatment for Hypoactive Sexual Desire Disorder in Premenopausal Women
PR-M06-19-NI-044
Botox
FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity
PR-M06-19-NI-043
Biosimilar Approval
Herceptin Biosimilar Approved in the U.S.
PAO-M06-19-NI-017
FDA Approval
FDA Approves Pembrolizumab for Metastatic Small Cell Lung Cancer
PR-M06-19-NI-038
FDA Approval
Genetech’s Antibody–Drug Conjugate Receives FDA Approval
PAO-M06-19-NI-010
FDA Approval
FDA Approves New Cochlear Implant with Easier Access to MRI and Expanded Connectivity Ready for Google's Direct Streaming to Android Smartphones
PR-M06-19-NI-030
FDA Approval
FDA Permits Marketing of First Medical Device for IBS Pain Relief in Adolescent Patients
PR-M06-19-NI-012
FDA Approval
TraceLink Gets FDA Approval for Participation in the Pilot Project Program
PAO-M05-19-NI-039
FDA Approval
FDA Approves SMA Gene Therapy
PAO-M05-19-NI-034
FDA Approval
FDA Approves First PI3K Inhibitor for Breast Cancer
PR-M05-19-NI-084
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