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Media Kit
FDA (3)
485 Articles Available
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Antigen Test
FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients
PR-M05-20-NI-022
FDA Authorization
Abbot Receives FDA Authorization for COVID-19 Antibody Blood Test System
PR-M05-20-NI-023
COVID-19
Trxade Group, Inc. Withdraws Its Previously Filed FDA Emergency Use Authorization for Rapid COVID-19 Testing Kit
PR-M05-20-NI-018
FDA
FDA Accepts for Priority Review Bristol Myers Squibb’s Application for CC-486 for Maintenance Treatment of Adult Patients in Remission with Acute Myeloid Leukemia
PR-M05-20-NI-012
FDA Approval
FDA Approves New Meningococcal Vaccination
PR-M04-20-NI-041
COVID-19 At-Home Testing
FDA Authorizes First Test for Patient At-Home Sample Collection
PR-M04-20-NI-037
FDA Approval
Roche Receives FDA Approval for Cobas HPV Test to Identify Women at Risk for Cervical Cancer
PR-M04-20-NI-031
FDA Statement
FDA Statement on Oral Fluid Test for COVID-19
PR-M04-20-NI-027
Priority Review
FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola
PR-M04-20-NI-025
COVID-19
COVID-19: A Look at the Virus, its Epidemiology, Therapeutic and Vaccine Development Efforts and Impacts of the Pandemic
PAO-Q2-20-NI-001
FDA
FDA Expedites Review of Diagnostic Tests to Combat COVID-19
PR-M03-20-NI-043
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
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