The FDA’s Drug Safety Oversight Board was formed
On Feb. 15, 2005, in response to concerns about the safety of a number of prescription medicines, the…
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Biotechnology | Diagnostics | Disease | FDA | Nanotechnology | Oncology | Therapeutics
FDA approved albumin-stabilized nanoparticle formulation of paclitaxel for treatment of breast cancer
In Jan. 2005, the U.S. Food and Drug Administration (FDA) approved an albumin-stabilized nanoparticle formulation of paclitaxel (Abraxane)…
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FDA approved Kepivance for severe oral mucositis in cancer patients undergoing bone marrow transplant
On Dec. 15, 2004, Amgen announced that following priority review, the FDA has approved Kepivance(TM) (palifermin), the first…
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Biotechnology | Disease | FDA | Oncology | Therapeutics
Genentech drug Tarceva (erlotinib) was approved
On Nov. 18, 2004, the U.S. Food and Drug Administration (FDA) announced it had approved Genentech’s drug Tarceva…
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Biotechnology | Disease | FDA | Oncology | Therapeutics | Women's Health
Letrozole was approved by the FDA for the adjuvant treatment of early-stage breast cancer after five years of tamoxifen therapy
On Oct. 29, 2004, the U.S. Food and Drug Administration (FDA) approved Letrozole for the extended adjuvant treatment…
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UI Microbiology Professor Mark Stinski made the discoveries of CMV promoter and was named Iowa Inventor of the Year
On Sept. 30, 2003, University of Iowa (UI) Microbiology Professor Mark Stinski made the discoveries of CMV promoter…
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A significant shortage of influenza vaccine occurred in the U.S.
On Aug. 25, 2004, a significant shortage of influenza vaccine occurred in the U.S. as a result of…
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Eli Lilly and Company launched new antidepressant Cymbalta
On Aug. 24, 2004, Eli Lilly and Company launched Cymbalta (duloxetine HC), a new treatment for major depression…
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Biotechnology | Chemistry | Diagnostics | FDA | Infectious Disease | Radiology | Therapeutics | U.S. Congress
Project BioShield Act authorized FDA to expedite review procedures for treatments for chemical, biological and nuclear agents
On Jul. 21, 2004, Project BioShield Act of 2004 was signed by President George W. Bush. The Act…
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Biotechnology | Diagnostics | FDA | NIH | Oncology
The FDA and NCI announced they will share knowledge and resources to facilitate development of new cancer drugs
On Mar. 16, 2004, the Food and Drug Administration (FDA) released a report addressing the recent slowdown in…
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Biotechnology | FDA | Medicine | Oncology | Therapeutics
FDA approved the first antiangiogenic drug for cancer, Avastin
On Feb. 26, 2004, the U.S. Food and Drug Administration (FDA) announced it had approved the first antiangiogenic…
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FDA banned dietary supplements containing ephedrine alkaloids
On Feb. 9, 2004, deeming such products to present an unreasonable risk of harm, the FDA banned dietary…
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Biotechnology | FDA | Oncology | Therapeutics
The monoclonal antibody cetuximab (Erbitux) was approved by the FDA for the treatment of metastatic colorectal cancer
On Feb. 1, 2004, the U.S. Food and Drug Administration (FDA) announced it had approved Cetuximab, a recombinant…
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Biotechnology | Disease | FDA | Oncology | Therapeutics
The FDA approved oxaliplatin (Eloxatin) for use in the treatment of advanced colorectal cancer
On Jan. 9, 2004, the Food and Drug Administration (FDA) announced the approval of Sanofi’s Eloxatin (oxaliplatin) injection…
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Biotechnology | Diagnostics | FDA | NIH | Oncology | Therapeutics
The National Cancer Institute collaborated with the Department of Health and Human Services to establish National Network of Tobacco Cessation Quitlines
In 2004, the National Cancer Institute (NCI) collaborated with the Department of Health and Human Services to establish…
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Siteman Cancer Center established a Good Manufacturing Practice (GMP) facility
In 2004, the Siteman Cancer Center established a Good Manufacturing Practice (GMP) facility, the first built in partnership…
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FDA issued public health advisory urging health professionals to limit the use of Cox-2 selective agents
In 2004, Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) because of an increased risk of heart…
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FDA published “Innovation or Stagnation? — Challenge and Opportunity on the Critical Path to New Medical Products”
In 2004, the FDA published “Innovation or Stagnation? — Challenge and Opportunity on the Critical Path to New…
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The Emergency Use Authorization program was established
In 2004, the Emergency Use Authorization (EUA) program was established in 2004, when the Project BioShield Act, among…
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Cialis Was Approved by the FDA
On Nov. 21, 2003, Cialis (tadalafil), discovered through a Glaxo Wellcome and ICOS Corp. partnership, was first approved…
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The Animal Drug User Fee Act permits FDA to collect subsidies for the review of certain animal drug applications from sponsors
On Nov. 18, 2003, the U.S. Congress passed the Animal Drug User Fee Act (ADUFA) which permitted the…
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An obesity working group is established by the Commissioner of Food and Drugs
On Oct. 8, 2003, an obesity working group was established by the Commissioner of Food and Drugs, charged…
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Biotechnology | Disease | FDA
FDA approved an expanded indication for ENBREL (etanercept) to inhibit progression of structural damage of active arthritis
On Aug. 25, 2003, The U.S. Food and Drug Administration (FDA) announced it had approved an expanded indication…
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The FDA announced food labels to include trans fat content
On Jul. 11, 2003, the U.S. Food and Drug Administration (FDA) published a final rule in the Federal…
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Biotechnology | Disease | FDA | Therapeutics
FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure
On Feb. 16, 2024, Genentech drug Xolair (omalizumab) was approved by the U. S. Food and Drug Administration…
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The first nasally administered influenza vaccine (FluMist by MedImmune) was licensed
On Jun. 17, 2003, the U.S. Food and Drug Administration (FDA) announced it had approved FluMist. This was…
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Biotechnology | FDA | Oncology | Therapeutics
The FDA approved the drug bortezomib (Velcade) for the treatment of multiple myeloma
On May 13, 2003, the U.S. Food and Drug Administration (FDA) granted accelerated approval for bortezomib (formerly PS-341), Velcade®…
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Agriculture | Biotechnology | FDA | USDA
The National Academy of Sciences released “Scientific Criteria to Ensure Safe Food”
On Apr. 7, 2003, the National Academy of Sciences released “Scientific Criteria to Ensure Safe Food,” a report…
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Biotechnology | Disease | FDA | Medicine | Therapeutics
Long-term efficacy and safety of etanercept was found in children with polyarticular-course juvenile rheumatoid arthritis
On Jan. 10, 2003, long-term efficacy and safety of etanercept (Enbrel) was found in children with polyarticular-course juvenile…
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Two randomized controlled trials showed that taking aspirin daily for as little as three years reduces the development of colorectal polyps
In 2003, two randomized controlled trials showed that taking aspirin daily for as little as three years reduces…
