Biotechnology | FDA | Polio | Vaccine
FDA licensed Sanofi Pasteur’s new pediatric combination vaccine, Pentacel
On Jun. 23, 2008, Sanofi Pasteur announced the U.S. Food and Drug Administration (FDA) had licensed Pentacel, Diphtheria…
FDA approved Pentacel, a new combination DTaP-IPV-Hib vaccine for use in children 6 wksﾖ4 yrs of age
On Jun. 20, 2008, the FDA approved Pentacel (Sanofi Pasteur), a new combination DTaP-IPV-Hib vaccine for use in…
FDA approved the use of Sanofi Pasteur’s Tenivac tetanus and diphtheria toxoids
On Jun. 5, 2008, the FDA approved the use of Sanofi Pasteur’s Tenivac tetanus and diphtheria toxoids adsorbed…
FDA approved new rotavirus vaccine for use in U.S.
On Apr. 3, 2008, the U.S. Food and Drug Administration (FDA) approved new rotavirus vaccine (Rotarix) for use…
Biotechnology | Disease | FDA | Therapeutics
ZymoGenetics received FDA authorization to manufacture the product Thrombin topical (Recombinant)
On Jan. 17, 2008, ZymoGenetics received U.S. Food and Drug Administration (FDA) authorization to manufacture the product Thrombin…
FDA approved Afluria, a new inactivated influenza vaccine for use in people age 18 years and older
On Sept. 28, 2007, the U.S. Food and Drug Administration (FDA) approved an Australian-made influenza vaccine called Afluria…
The FDA Amendments Act of 2007 reauthorized collection of prescription drug user fees
On Sept. 27, 2007, the FDA Amendments Act of 2007 amended the Federal Food, Drug, and Cosmetic Act…
FDA approved use of FluMist nasal-spray influenza vaccine in children age 2-5 years
On Sept. 20, 2007, the U.S. Food and Drug Administration (FDA) approved use of FluMist nasal-spray influenza vaccine…
Biotechnology | Disease | FDA | Oncology | Therapeutics | Women's Health
The FDA approved Eli Lilly and Company’s osteoporosis drug, Evista, to reduce the risk of invasive breast cancer
On Sept. 14, 2007, the U.S. Food and Drug Administration (FDA) announced it had approved Eli Lilly’s osteoporosis…
OHSU became the first in Oregon to offer a new artificial disk for the neck
On Aug. 2, 2007, Oregon Health and Science University (OHSU) became the state’s only medical center to implant…
FDA approved the H5N1 vaccine, the first vaccine approved for avian flu
On Apr. 17, 2007, Sanofi announced that the U.S. Food and Drug Administration (FDA) had licensed its H5N1…
FDA approved an accelerated dosing schedule for Twinrix (hepatitis A and B vaccine)
On Mar. 28, 2007, the FDA announced that GlaxoSmithKline (King of Prussia, Pennsylvania) received approval for an alternate…
Eli Lilly completed its acquisition of ICOS Corp for $23 billion
On Jan. 29, 2007, Eli Lilly announced it had completed its acqusition of ICOS Corp. for $2.3 billion…
FDA licensed the refrigerator formulation of FluMist
On Jan. 9, 2007, the U.S. Food and Drug Administration (FDA) announced it had approved a refrigerated form…
Biotechnology | Diagnostics | Disease | FDA | Therapeutics
FDA approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease
In 2007, the U.S. Food and Drug Administration (FDA) approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Therapeutics | Women's Health
FDA approved trastuzumab for use with other drugs in adjuvant treatment of women with early-stage, node-positive, HER2-overexpressing breast cancer
On Nov. 16, 2006, the U.S. Food and Drug Administration (FDA) approved Genentech’s trastuzumab (Herceptin) for use with…
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…