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FDA
426 Articles Available
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Biohaven to Advance Vazegepant Into Phase 3 for Acute Migraine Treatment
COVID-19 Test
Mesa Biotech Receives Emergency Use Authorization from FDA for a 30 Minute Point of Care Molecular COVID-19 Test
PR-M03-20-NI-039
FDA Takes Action to Increase U.S. Supplies Through Instructions for PPE and Device Manufacturers
PR-M03-20-NI-038
Clinical Trials
FDA Urges Remote Clinical Trials
PR-M03-20-NI-029
FDA
FDA Postpones Domestic Inspections Due to COVID-19 Outbreak
PR-M03-20-NI-028
Roche Ships 400,000 Coronavirus Test Kits to U.S.
PR-M03-20-NI-027
Coronavirus
FDA Postpones Foreign Inspections Due to Coronavirus Outbreak
PR-M03-20-NI-022
BLA
U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Bevacizumab for Review
PR-M03-20-NI-014
Coronavirus
Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics
PR-M03-20-NI-004
FDA Approval
Perrigo and Catalent Announce FDA Approval of Perrigo's AB-Rated Generic Version of ProAir® HFA
PR-M02-20-NI-041
Coronavirus
FDA Issues Statement on Ensuring Safety of Foreign Products During Coronavirus Outbreak
PR-M02-20-NI-035
Fast Track
FDA Grants Soligenix "Fast Track" Designation for RiVax® in the Prevention of Ricin Poisoning
PR-M02-20-NI-019
FDA Review
Avenue Therapeutics Announces New Drug Application for IV Tramadol Accepted for Review by FDA
PR-M02-20-NI-018
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
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