FDA approved Cervarix, GlaxoSmithKline’s cervical cancer vaccine
On Oct. 16, 2009, GlaxoSmithKline announced the U.S. Food and Drug Administration (FDA) had approved Cervarix [Human papillomavirus…
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FDA approved new indication for gardasil to prevent genital warts in men and boys
On Oct. 16, 2009, the U.S. Food and Drug Administration (FDA) approved new indication for gardasil to prevent…
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FDA approved four vaccines against the 2009 H1N1 influenza virus
On Sept. 15, 2009, the U.S. Food and Drug Administration (FDA) approved four Influenza A (H1N1) 2009 Monovalent…
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Vaccine Court ruled that MMR vaccine does not cause autism
On Feb. 12, 2009, the Vaccine Court ruled that MMR vaccine, when administered with thimerosal-containing vaccines, does not…
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FDA approved first genetically engineered animal for production of a recombinant form of human antithrombin
On Feb. 12, 2009, The US Food and Drug Administration issued its first approval for a biological product produced…
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FDA approved changes in the schedule for administering anthrax vaccine
On Dec. 19, 2008, the Food and Drug Administration (FDA) approved changes in the schedule for administering anthrax…
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FDA approved expanded indication for use of Boostrix Tdap vaccine in people ages 10-64 years
On Dec. 4, 2008, the Food and Drug Administration (FDA) approved an expanded age indication for the tetanus…
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The U.S. FDA opened its first foreign office in Beijing
On Nov. 19, 2008, the U.S. Food and Drug Administration opened its first foreign office in Beijing to…
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Biotechnology | FDA | Polio | Vaccine
FDA approved new DTaP-IPV vaccine (Kinrix) for use in children ages 4-6 years
On Jun. 24, 2008, GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) had approved KINRIX™ [Diphtheria…
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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…
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FDA approved Pentacel, a new combination DTaP-IPV-Hib vaccine for use in children 6 weeks-34 yrs of age
On Jun. 20, 2008, the Food and Drug Administration (FDA) licensed a combined diphtheria and tetanus toxoids and…
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Biotechnology | CDC | Diagnostics | FDA | Infectious Disease | Vaccine
CDC announced it had begun distribution of a new-generation smallpox vaccine
On Feb. 29, 2008, the U.S. Centers for Disease Control and Prevention (CDC) announced it had begun distribution…
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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…
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FDA Approved Cialis(R) (tadalafil) for Once Daily Use for the Treatment of Erectile Dysfunction
On Jan. 8, 2008, Eli Lilly announced that the U.S. Food and Drug Administration (FDA) had approved Cialis(R)…
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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…
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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…
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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…
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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…
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OHSU became the first in Oregon to offer a new artificial disk for the neck
On Aug. 16, 2007, surgeons at Oregon Health and Science University announced implanting a new artificial disc in…
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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…
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FDA approved an accelerated dosing schedule for Twinrix (hepatitis A and B vaccine)
On Mar. 28, 2007, the U.S. Food and Drug Administration (FDA) announced that GlaxoSmithKline (King of Prussia, Pennsylvania)…
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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…
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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…
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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…
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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…
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The FDA approved Glivec for Five Rare, Life-Threatening Disorders
On Oct. 19, 2006, the U.S. Food and Drug Administration (FDA) granted Glivec® (imatinib) has received US regulatory…
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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…
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ICOS Corp announced agreement to be acquired by Eli Lilly
On Oct. 18, 2006, ICOS announced it had signed an agreement to be acquired by Eli Lilly and…
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The Biomarkers Consortium was founded
On Oct. 5, 2006, the Foundation for the National Institutes of Health, NIH, FDA, and the Pharmaceutical Research…
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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 by the U.S. Food and Drug Administration (FDA) for…
