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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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…
Eli Lilly and Company launched Symbyax in the U.S.
On Apr. 19, 2004, Eli Lilly and Company launched Symbyax in the U.S., the first and only Food…
Tetanus and diphtheria toxoids adsorbed for adult use, preservative-free, was licensed
On Mar. 24, 2004, the U.S. Food and Drug Administration (FDA) licensed tetanus and diphtheria toxoids adsorbed for…
Biotechnology | Diagnostics | FDA | Life Science News | 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…
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…
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…
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…
The FDA approved oxaliplatin (Eloxatin) for use in the treatment of advanced colorectal cancer
On Jan. 9, 2004, the FDA announced the approval of Eloxatin (oxaliplatin) injection for initial treatment of advanced…
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…
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…
Letrozole was approved by the FDA for the adjuvant treatment of early-stage breast cancer after five years of tamoxifen therapy
In 2004, Letrozole was approved by the FDA for the adjuvant treatment of early-stage breast cancer after five…
Biotechnology | Diagnostics | FDA | Life Science News | 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…
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…
Cialis was approved by the FDA
On Nov. 21, 2003, Cialis (tadalafil), discovered through a Glaxo Wellcome and ICOS Corp. partnership, was approved by…
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…
FDA approved an expanded indication for ENBREL (etanercept) to inhibit progression of structural damage of active arthritis
On Aug. 25, 2003, the FDA approved an expanded indication for ENBREL (etanercept) to inhibit the progression of…
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…
Genentech drug Xolair (omalizumab) was approved
On Jun. 20, 2003, Genentech drug Xolair (omalizumab) was approved by the U. S. Food and Drug Administration…
The FDA approved the drug bortezomib (Velcade) for the treatment of multiple myeloma
On May 13, 2003, the FDA approved the drug bortezomib (Velcade) for the treatment of multiple myeloma. In…
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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…
Biotechnology | Disease | FDA | Life Science News | 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…
The Animal Drug User Fee Act permits FDA to collect subsidies for the review of certain animal drug applications from sponsors
In 2003, The Animal Drug User Fee Act permits FDA to collect subsidies for the review of certain…
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…
The FDA Office of Combination Products was formed
On Dec. 24, 2002, the FDA’s Office of Combination Products was formed within the Office of the Commissioner,…
Vaccine that combined diphtheria, tetanus, acellular pertussis, inactivated polio and hepatitis B antigens was licensed
On Dec. 13, 2002, the U.S. Food and Drug Administration (FDA) announced it had licensed a combined diphtheria…
Genentech drug Pegasys (peginterferon alfa-2a) approved
On Dec. 3, 2002, Genentech drug Pegasys (peginterferon alfa-2a) was approved by the Food and Drug Administration (FDA)…
NCI and FDA scientists reported patterns of proteins found in patients’ blood can distinguish between prostate cancer and benign conditions
On Oct. 16, 2002, patterns of proteins found in patients’ blood may help distinguish between prostate cancer and…
FDA announced initiative to modernize the regulation of pharmaceutical manufacturing
On Aug. 21, 2002, the FDA announced an initiative to modernize the regulation of pharmaceutical manufacturing and product…