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FDA
398 Articles Available
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FDA Approval
Sandoz Receives FDA Approval for Oncology Supportive Care Biosimilar Ziextenzo™
PR-M11-19-NI-006
FDA
The FDA Warns that Biotin May Interfere with Lab Tests
PR-M11-19-NI-005
FDA
Trump Nominates FDA Commissioner – and It Isn’t Sharpless
PAO-M11-19-NI-003
FDA
Compugen Announces FDA Clearance of IND Application for COM902
PR-M11-19-NI-003
Recall
FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)
PR-M10-19-NI-047
Glocalization
From Regulatory Convergence to Global Regulatory Harmonization
PAP-Q3-19-NI-004
FDA Guidance
Updating Ethical Guidelines for Cancer Clinical Trials
PAP-Q3-19-NI-006
Novel Therapies
Q: What do you identify as the greatest advances that have been achieved in recent years with respect to harmonization of pharmaceutical regulations?
PAP-Q2-19-NI-007
FDA Approval
GSK Announces U.S. Food and Drug Administration Approval of Additional Indication for Zejula (niraparib) for Late-line Treatment for Women with Recurrent Ovarian Cancer
PR-M10-19-NI-035
FDA Approval
Janssen Announces U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
PR-M10-19-NI-032
FDA Priority Review
[Fam-] Trastuzumab Deruxtecan Granted FDA Priority Review for Treatment of Patients With HER2-positive Metastatic Breast Cancer
PR-M10-19-NI-025
FDA Approval
FDA Approves New Treatment for Patients with Migraine
PR-M10-19-NI-023
Diagnostics
FDA Allows Marketing of First Rapid Diagnostic Test for Detecting Ebola Virus Antigens
PR-M10-19-NI-019
HIV Prevention
FDA Approves Second Drug to Prevent HIV Infection as Part of Ongoing Efforts to End the HIV Epidemic
PR-M10-19-NI-008
FDA
FDA Encourages Inclusion of Male Patients in Breast Cancer Clinical Trials
PR-M10-19-NI-005
FDA Leadership
Several Candidates are Contending for the Top FDA Job
PAO-M09-19-NI-022
Recall
Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets
PR-M09-19-NI-055
Recall
FDA Announces Voluntary Recall of Sandoz Ranitidine Capsules Following Detection of an Impurity
PR-M09-19-NI-049
Data Integrity
Novartis Pledges 5-Day Response Regarding Future Data Integrity Issues
PAO-M09-19-NI-020
Drug Pricing
FDA CDER Head Castigates Pharma Industry
PAO-M09-19-NI-017
Phase II
Hovione Announces Successful End-of-Phase 2 Meeting with the FDA and Outlines Phase 3 Program for Minocycline Topical Gel
PR-M09-19-NI-047
FDA
Statement Alerting Patients and Health Care Professionals of NDMA Found in Samples of Ranitidine
PR-M09-19-NI-043
Fast Track Designation
FDA Grants Fast Track Designation for Farxiga in Heart Failure
PR-M09-19-NI-042
FDA Clearance
New Vision System for Tracking Eye Movement Gets FDA Clearance
PAO-M09-19-NI-014
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