The FDA approved Gleevec for Five Rare, Life-Threatening Disorders
On Oct. 19, 2006, the U.S. Food and Drug Administration (FDA) approved the drug, Gleevec developed by Oregon…
ICOS Corp announced agreement to be acquired by Eli Lilly and Company
On Oct. 18, 2006, ICOS announced it had signed an agreement to be acquired by Eli Lilly and…
The Biomarkers Consortium was founded
On Oct. 5, 2006, the Foundation for the National Institutes of Health, NIH, FDA, and the Pharmaceutical Research…
Eli Lilly and Company’s Gemzar was approved for use in the treatment of women living with recurrent ovarian cancer
On Jul. 17, 2006, Eli Lilly and Company’s Gemzar was approved for use in the treatment of women…
Genentech drug Lucentisﾙ (ranibizumab injection) was approved
On Jun. 30, 2006, Genentech drug Lucentisﾙ (ranibizumab injection) was approved by the FDA for the treatment of…
The FDA approved the vaccine Gardasil for HPV
On Jun. 8, 2006, the FDA approved the vaccine Gardasil, which protects against persistent infection by the two…
Zostavax was approved by the FDA to prevent shingles (herpes zoster) in individuals 60 years of age and older
On May 25, 2006, Zostavax, manufactured by Merck & Co. of Whitehouse Station, New Jersey, was approved by…
VariZIG became available under an IND Expanded Access Protocol
On Feb. 24, 2006, the Advisory Committee on Immunization Practices (ACIP) was informed by the only U.S.-licensed manufacturer…
Calistoga Pharmaceuticals was founded
In 2006, Calistoga Pharmaceuticals was founded as a Seattle-based spin-off from ICOS Corp. that was dedicated to developing…
Final order on the anthrax vaccine was issued by FDA
On Dec. 19, 2005, in a 2-year legal battle over the U.S. military’s anthrax vaccination program, the Food…
Agriculture | Biology | Diagnostics | FDA | Therapeutics | U.S. Congress
Passage of Food Allergy Labeling Act required labeling of foods that may cause allergic reaction
On Dec. 12, 2005, the U.S. Congress approved the passage of the Food Allergy Labeling and Consumer Protection…
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 | 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 | 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…
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…
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…
Biotechnology | Chemical | 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…
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 | 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…