Crohn Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2011-10-07FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)
The FDA approved Biogen's supplemental application for TYSABRI (natalizumab), resulting in a labeling update as part of a supplemental appro…
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FDA approval · 2011-09-16FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)
The FDA approved Biogen's supplemental application for Tysabri (Natalizumab).
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FDA approval · 2011-09-07FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)
FDA approved a supplemental application for Cimzia (certolizumab pegol) submitted by UCB, Inc. This action approves the changes described in…
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FDA approval · 2011-06-23FDA Approved: BUDESONIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for budesonide from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2011-05-27FDA Approved: MERCAPTOPURINE — Supplemental Application (Florida Pharmaceutical Products, LLC)
The FDA has approved a supplemental application for mercaptopurine from Florida Pharmaceutical Products, LLC.
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FDA approval · 2011-04-01FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)
FDA approved a supplemental application for TYSABRI (Natalizumab) filed by Biogen Inc. The action represents an approved regulatory update t…
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FDA approval · 2011-03-23FDA Approved: AZATHIOPRINE — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for azathioprine from Rising Pharma Holdings, Inc., under an existing ANDA. This action confirms the…
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FDA approval · 2011-02-17FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)
The FDA approved a supplemental application for infliximab from Janssen Biotech, Inc., signaling a labeling update or expansion of its appro…
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FDA approval · 2011-01-20FDA Approved: SULFASALAZINE — Supplemental Application (Sunrise Pharmaceutical, Inc.)
FDA approved a supplemental application submitted by Sunrise Pharmaceutical, Inc. under ANDA040349 to market a generic form of sulfasalazine…
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FDA approval · 2010-12-28FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)
FDA approved Janssen Biotech, Inc.'s supplemental application for infliximab. The approval updates the product's labeling and indications as…
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FDA approval · 2010-07-29FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)
The FDA has approved a supplemental application for HUMIRA (adalimumab) filed by Cordavis Limited.
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FDA approval · 2010-07-29FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)
The FDA approved a supplemental application for CIMZIA (certolizumab pegol) submitted by UCB, Inc., resulting in an approved amendment to it…
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FDA approval · 2010-01-21FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)
The FDA approved a supplemental application for TYSABRI (Natalizumab) from Biogen Inc. The approval updates the drug's label and indications…
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FDA approval · 2009-12-30FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for ustekinumab submitted by Janssen Biotech, Inc.
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FDA approval · 2009-05-13FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)
The FDA approved a supplemental application for CIMZIA (certolizumab pegol) submitted by UCB, Inc.
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FDA approval · 2008-08-25FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)
The FDA approved Biogen's supplemental application for TYSABRI (natalizumab), updating its labeling and/or indication.
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FDA approval · 2008-08-12FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)
The FDA approved Biogen's supplemental application for TYSABRI (natalizumab).
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FDA approval · 2008-04-22FDA Approved: CIMZIA — Original Application (UCB, Inc.)
The FDA approved Cimzia (certolizumab pegol) in its original Biologics License Application, marking its initial approval for Crohn's disease…
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FDA approval · 2007-07-30FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)
The FDA approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited.
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FDA approval · 2007-06-26FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Pentasa (mesalamine) from Takeda Pharmaceuticals America, resulting in an approved additiona…
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FDA approval · 2007-06-12FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for infliximab (Remicade) submitted by Janssen Biotech, Inc. The approval updates the labeling to re…
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FDA approval · 2007-04-19FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)
The FDA approved a supplemental application for infliximab (Remicade) from Janssen Biotech, Inc., updating the product labeling per the supp…
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FDA approval · 2006-12-08FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for infliximab submitted by Janssen Biotech, Inc.
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FDA approval · 2006-09-26FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)
The FDA approved a supplemental application for infliximab from Janssen Biotech, Inc., updating the drug's labeling.
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FDA approval · 2006-07-28FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)
FDA approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited, likely to authorize a new contract manufactur…