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Recall
Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products
PR-M07-19-NI-036
FDA Approval
FDA Grants Additional Myeloma Approval to J&J’s Darzalex
PAO-M07-19-NI-014
Leadership
Gottlieb Joins Pfizer Board of Directors
PAO-M07-19-NI-013
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
Phase II
Iovance Biotherapeutics Provides Cervical Cancer Program Updates Following End of Phase 2 Meeting with U.S. Food and Drug Administration (FDA)
PR-M07-19-NI-016
FDA
FDA Warns Patients and Healthcare Providers About Potential Cybersecurity Concerns with Certain Medtronic Insulin Pumps
PR-M07-19-NI-012
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
Priority Review
Melinta’s Antibiotic Baxdela Gets Priority Review from FDA for CAPB
PAO-M07-19-NI-005
FDA
FDA Considering Drug Designed to Improve Sexual Desire
PAO-M07-19-NI-004
Clinical Trials
FDA Provides Guidance on Increasing Clinical Trial Diversity
PAO-M07-19-NI-003
FDA Approval
FDA Approves First Treatment for Chronic Rhinosinusitis with Nasal Polyps
PR-M07-19-NI-003
FDA Fast Track
U.S. FDA Grants Fast Track Designation to Empagliflozin for the Treatment of Chronic Heart Failure
PR-M06-19-NI-058
Drug Approval
FDA Expands Approval of Treatment for Cystic Fibrosis to Include Patients Ages 6 and Older
PR-M06-19-NI-056
FDA Review
Daiichi Sankyo Provides Update on FDA Review of Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
PR-M06-19-NI-045
Clinical Trials
Krystal Biotech Announces Positive Results from Phase 2 Clinical Trial and Receives Regenerative Medicine Advanced Therapy Designation
PR-M06-19-NI-047
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
Breakthrough Device Designation
FDA Grants Breakthrough Device Designation to Bio-Techne's ExoDx™ Prostate IntelliScore™ (EPI) Test
PR-M06-19-NI-029
FDA Approval
FDA Permits Marketing of First Medical Device for IBS Pain Relief in Adolescent Patients
PR-M06-19-NI-012
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