Historical FDA documents
FDA press releases and papers from the agency's history, as full text. 8,858 records; openFDA updated it 2026-10-02. About this dataset
Newest records
- For Immediate Release - October 3, 2014
FDA News Release For Immediate Release - October 3, 2014 FDA seeks permanent injunction against Pharmaceutical Innovations, Inc. Defendants charged with distributing adulterated and misbranded medical devices The U.S. F…
- For Immediate Release - September 22, 2014
FDA News Release For Immediate Release - September 22, 2014 FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample The U.S. Food and Drug Administration today allowed market…
- For Immediate Release - July 28, 2014
FDA News Release For Immediate Release - July 28, 2014 FDA expands approved use of Imbruvica for chronic Iymphocytic leukemia New clinical data supports traditional approval for CLL The U.S. Food and Drug Administration…
- For Immediate Release - October 17, 2014
FDA News Release For Immediate Release - October 17, 2014 FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic The U.S. Food and Drug Administration today approved new labeling…
- For Immediate Release: March 11, 2014
FDA NEWS RELEASE For Immediate Release: March 11, 2014 Espafiol FDA allows marketing of first medical device to prevent migraine headaches Today, the U.S. Food and Drug Administration allowed marketing of the first devic…
- FDA News Release For Immediate Release - December 8, 2014
FDA News Release For Immediate Release - December 8, 2014 OtisMed Corporation, former CEO plead guilty for distributing FDA-rejected cutting guides for knee replacement surgeries Corporation to pay more than $80 million…
- For Immediate Release - July 3, 2014
FDA News Release For Immediate Release - July 3, 2014 FDA approves Beleodaq to treat rare, aggressive form of non-Hodgkin lymphoma The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treat…
- For Immediate Release: April 3, 2014
FDA NEWS RELEASE For Immediate Release: April 3, 2014 Espafiol FDA approves new hand-held auto-injector to reverse opioid overdose First naloxone treatment specifically designed to be given by family members or caregivers…
- For Immediate Release - August 1, 2014
FDA News Release For Immediate Release - August 1, 2014 FDA expands approval of drug to treat Pompe disease to patients of all ages; removes risk mitigation strategy requirements The U.S. Food and Drug Administration to…
- For Immediate Release - June 24, 2014
FDA News Release For Immediate Release - June 24, 2014 FDA issues guidance to support the responsible development of nanotechnology products Today, three final guidances and one draft guidance were issued by the U.S. Fo…
- For Immediate Release: Jan. 17, 2014
FDA NEWS RELEASE For Immediate Release: Jan. 17, 2014 En Espafiol FDA allows marketing for first of-its-kind post-natal test to help diagnose developmental delays and intellectual disabilities in children Today the U.S.…
- For Immediate Release - August 19, 2014
FDA News Release For Immediate Release - August 19, 2014 FDA approves new drug to treat a form of Gaucher disease The U.S. Food and Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of…
- For Immediate Release - May 21, 2014
FDA News Release For Immediate Release - May 21, 2014 FDA approves first molecular (gene-based) test to determine red blood cell types in transfusion medicine The U.S. Food and Drug Administration today approved the Imm…
- For Immediate Release: Feb. 13, 2014
FDA NEWS RELEASE For Immediate Release: Feb. 13, 2014 Illegal prescription drug sellers arraigned on charges for smuggling illicit cancer drugs into the United States Two individuals today were arraigned for charges tha…
- For Immediate Release - September 18, 2014
FDA News Release For Immediate Release - September 18, 2014 FDA approves Trulicity to treat type 2 diabetes Espafiol The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneou…
- For Immediate Release - May 30, 2014
FDA News Release For Immediate Release - May 30, 2014 FDA approves first generic versions of celecoxib The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a…
- For Immediate Release: March 19, 2014
FDA NEWS RELEASE For Immediate Release: March 19, 2014 FDA approves Impavido to treat tropical disease leishmaniasis The U.S. Food and Drug Administration today approved Impavido (miltefosine) to treat a tropical diseas…
- For Immediate Release - December 22, 2014
FDA News Release For Immediate Release - December 22, 2014 FDA approves Opdivo for advanced melanoma The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for pa…
- For Immediate Release: Jan. 31, 2014
FDA NEWS RELEASE For Immediate Release: Jan. 31, 2014 On Oct. 2, 2014 this release was updated with a change to the first and second paragraphs to clarify the approved use (indication) of Hetlioz. The drug labeling (pre…
- For Immediate Release: April 29, 2014
FDA NEWS RELEASE For Immediate Release: April 29, 2014 FDA approves Zykadia for late-stage lung cancer Breakthrough therapy drug approved four months ahead of review completion goal date The U.S. Food and Drug Administr…
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.