FDA approved lowering the age limit to 12 mos for remaining US-licensed hepatitis A vaccine in the US
On Oct. 17, 2005, the FDA approved lowering the age limit to 12 mos for the remaining U.S.-licensed…
FDA approved lowering the age limit to 12 mos for one of the two licensed hepatitis A vaccine
On Aug. 11, 2005, the Food and Drug Administration (FDA) approved an application of a pediatric/adolescent formulation of…
FDA licensed a 2nd Tdap vaccine (Adacel by Sanofi Pasteur) for use in persons ages 11-64 years
On Jun. 9, 2005, the U.S. Food and Drug Administration (FDA) licensed a 2nd Tdap vaccine (Adacel by…
Amylin Pharmaceuticals and Eli Lilly annnounced Byettaﾮ approved and launched in the US
On Apr. 29, 2005, Amylin Pharmaceuticals and Eli Lilly announced the FDA had approved BYETTA(TM) (exenatide) injection as…
Sanofi Pasteur announced FDA approval of Menactra meningococcal conjugate vaccine indication for infants
On Apr. 22, 2005, Sanofi Pasteur announced the U.S. Food and Drug Administration (FDA) had granted licensure to…
The National Cancer Institute and FDA established an NCI-FDA Research and Regulatory Review Fellowship program
On Feb. 16, 2005, in preparation for the new generation of molecular-based oncology medical products, the National Cancer…
Formation of the Drug Safety Board was announced
On Feb. 16, 2005, Formation of the Drug Safety Board was announced, consisting of FDA staff and representatives…
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…
Biotechnology | Diagnostics | Disease | FDA | Life Science News | 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)…
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…
Biotechnology | Disease | FDA | Life Science News | 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…
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…
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…
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…
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…
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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…
Biotechnology | Disease | FDA | Life Science News | 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…
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…
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…
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…