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U.S. Food and Drug Administration (FDA) News

FDA gives clearance for Great Basin E.coli test

Wednesday, Mar 30, 2016 @ 12:21pm by BioPrepWatch Reports

The U.S.
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FDA approves new inhalational anthrax treatment

Friday, Mar 25, 2016 @ 2:59pm by BioPrepWatch Reports

Officials with the U.S. Food and Drug Administration (FDA) recently approved the Anthim (obiltoxaximab) injection, to be used with specific antibacterial drugs to treat people who have had inhalational anthrax.
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SIGA Technologies reaches final stages of smallpox drug trial

Tuesday, Mar 1, 2016 @ 7:53pm by BioPrepWatch Reports

SIGA Technologies has reached the final stages of its clinical trial for a drug that could cure small pox.
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FDA issues new blood donation guidelines due to Zika threat

Thursday, Feb 18, 2016 @ 5:50pm by BioPrepWatch Reports

The U.S. Food and Drug Administration (FDA) has issued new guidelines for donating blood to travelers that have visited countries with outbreaks of the Zika virus.
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FDA issues request for public comment on clinical trial design

Wednesday, Dec 30, 2015 @ 4:00pm by BioPrepWatch Reports

The FDA is seeking public commentary regarding the designs of clinical trials related to emerging diseases.
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FDA discusses latest E. coli outbreak

Monday, Dec 7, 2015 @ 3:07pm by BioPrepWatch Reports

The FDA issued an update on a multi-state outbreak of E. coli this week.
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Avita Medical’s ReCell device heralds new wave of specialized wound treatment

Wednesday, Nov 25, 2015 @ 10:26am by BioPrepWatch Reports

With a new contract that could top almost $54 million and a just-announced patent, Avita Medical, Ltd. CEO Adam Kelliher said further development of the company's ReCell technology is in full swing.
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FDA approves increased indication for BioThrax vaccine

Tuesday, Nov 24, 2015 @ 4:27pm by BioPrepWatch Reports

The Food and Drug Administration (FDA) issued an updated indication for the BioThrax vaccine on Monday.
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Bavarian Nordic initiates Sierra Leone Ebola vaccine study

Wednesday, Oct 14, 2015 @ 5:28pm by BioPrepWatch Reports

This study acts as a parallel track to similar studies being conducted in the United States, Africa and Europe. Studies in the U.K.
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VIBATIV shows promise in fight against MRSA

Friday, Sep 25, 2015 @ 2:44pm by BioPrepWatch Reports

The Food and Drug Administration (FDA) has accepted a supplemental New Drug Application from Theravance Biopharma for its drug VIBATIV (telavancin), which combats hospital-acquired and ventilator-associated bacterial pneumonia. 
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Antibody drug for Ebola advanced by HHS

Monday, Sep 21, 2015 @ 3:46pm by BioPrepWatch Reports

The Department of Health and Human Services (HHS) announced on Monday that it has advanced the development of a antibody-based treatment candidate for the Ebola virus.
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FDA accepts Theravance Biopharma sNDA on Vibativ

Friday, Sep 11, 2015 @ 6:10pm by BioPrepWatch Reports

Theravance Biopharma, Inc. said Thursday that the the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for its drug Vibativ ( telavancin) to expand its label to include treatment of Staphylococcus aureus.
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Canada adds another layer to ebola preparedness

Tuesday, Jun 16, 2015 @ 10:36am by BioPrepWatch Reports

Government signs deal with Mapp Biopharmaceutical for ZMapp production
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Navy Health Research Center concludes smallpox vaccine study

Friday, Jan 23, 2015 @ 3:07pm by BioPrepWatch Reports

The Naval Health Research Center (NHRC) has concluded its study in partnership with the U.S.
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FDA's Pharmacy Compounding Committee named

Tuesday, Dec 16, 2014 @ 2:33pm by BioPrepWatch Reports

The U.S. Food and Drug Administration (FDA) announced the appointment of 14 members to its Pharmacy Compounding Committee today.
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ARCA compound receives orphan drug designation

Wednesday, Dec 10, 2014 @ 2:43pm by BioPrepWatch Reports

The U.S. Food and Drug Administration (FDA) gave orphan drug designation to ARCA biopharm, Inc.'s rNAPc2 compound as a potential treatment for Ebola on Wednesday.
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Emergent BioSolutions seeking expanded label for anthrax vaccine

Tuesday, Nov 11, 2014 @ 12:23pm by BioPrepWatch Reports

Emergent BioSolutions Inc. is asking the U.S. Food and Drug Administration (FDA) to allow it to include a post-exposure prophylaxis (PEP) indication on its BioThrax label, the company announced on Monday.
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FDA highlights regulatory science collaborations aimed at emergency preparedness efforts

Friday, Oct 10, 2014 @ 4:12pm by BioPrepWatch Reports

The Federal Drug Administration’s FDA Voice publication recently highlighted collaborations between regulatory organizations in the science community that enhance emergency preparedness efforts Jean Hu-Primmer, M.S.
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FDA opens biodefense laboratory complex in White Oak, Md.

Tuesday, Oct 7, 2014 @ 2:42pm by BioPrepWatch Reports

The U.S. Food and Drug Administration (FDA) opened a new biodefense laboratory complex at the White Oak Campus in White Oak, Maryland, on Sept. 26.
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FDA issues Food Safety Challenge

Wednesday, Sep 24, 2014 @ 7:25am by BioPrepWatch Reports

The Food and Drug Administration (FDA) has issued the Food Safety Challenge in order to discover groundbreaking methods for detecting disease-causing agents in food.
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