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FDA (4)
485 Articles Available
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Biologics
FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products
PR-M02-20-NI-016
Priority Review
Novartis Lung Cancer Drug Granted Priority FDA Review
PR-M02-20-NI-010
FDA
Olympus Announces FDA Clearance of the TJF-Q190V Duodenoscope
PR-M02-20-NI-008
FDA Clearance
Sony Announces FDA Clearance for NUCLeUS, the Smart Operating Room Platform, for Sale in the U.S.
PR-M02-20-NI-002
FDA Approval
FDA Approves Aimmune’s PALFORZIA™ as First Treatment for Peanut Allergy
PR-M01-20-NI-049
Insomnia
New Insomnia Treatment Approved by the FDA for Adults
PR-M01-20-NI-002
FDA Acceptance
Averitas Pharma Announces FDA Acceptance for Neuropathic Pain Treatment
PR-M12-19-NI-032
Biosimilars
FDA Statement on Low-Cost Biosimilar and Interchangeable Protein Products
PR-M12-19-NI-037
Ebola Vaccine
FDA Approves First Vaccine for the Prevention of Ebola Virus Disease
PR-M12-19-NI-035
PR-M12-19-NI-018
FDA Grants Orphan Drug Designation to Epidermolysis Bullosa Treatment
FDA Warning
FDA Sends Warning to Companies for Offering Unapproved Umbilical Cord Blood Products
PR-M12-19-NI-019
Quality Compliance
How a Quality Culture Contributes to Global Compliance
PAP-Q4-19-CL-007
Collaboration
Piramal Pharma Solutions Announces Collaboration with BerGenBio on the Development of FDA Fast Track Designated Leukemia Treatment
PR-M12-19-NI-005
FDA Approval
FDA Approves First Treatment for Inherited Rare Disease
PR-M12-19-NI-001
FDA Approval
Medtronic Drug-Coated Balloon Receives U.S. FDA Approval to Treat Arteriovenous Fistula Lesions
PR-M11-19-NI-033
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
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