PROVENGE was approved by the FDA
On Apr. 29, 2010, the FDA approved sipuleucel-T (PROVENGE), made by the Dendreon Corp., an autologous cellular immunotherapy…
FDA recommended physicians suspend use of GSK’s Rotarix rotavirus vaccine due to porcine circovirus 1 contamination
On Mar. 23, 2010, the U.S. Food and Drug Administration (FDA) recommended that physicians temporarily suspend use of…
FDA approved licensure of Pneumococcal 13-valent conjugate vaccine
On Feb. 24, 2010, a 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals, a subsidiary of Pfizer])…
FDA approved licensure of Menveo (Novartis), meningococcal conjugate vaccine
On Feb. 19, 2010, the U.S. Food and Drug Administration (FDA) announced it had licensed a quadrivalent meningococcal…
FDA Approves Tocilizumab for Treatment of Rheumatoid Arthritis
On Jan. 11, 2010, the U.S. Food and Drug Administration (FDA) approved Genentech’s tocilizumab (Actemra) for the treatment…
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…
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…
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…
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…
FDA approved first genetically engineered animal for production of a recombinant form of human antithrombin
On Feb. 6, 2009, the U.S. Food and Drug Administration (FDA) approved the first genetically engineered animal for…
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…
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…
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…
Biotechnology | FDA | Polio | Vaccine
FDA approved new DTaP-IPV vaccine (Kinrix) for use in children ages 4-6 years
On Jun. 24, 2008, the U.S. Food and Drug Administration (FDA) licensed a combined diphtheria and tetanus toxoid…
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 had licensed Pentacel, Diphtheria and…
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…