The FDA approved Seattle Genetics’ Adcetris (brentuximab vedotin)
On Aug. 19, 2011, the U.S. Food and Drug Administration (FDA) approved Seattle Genetics’ Adcetris (brentuximab vedotin), making…
Genentech medicine approved for certain type of melanoma
On Aug. 17, 2011, Genentech announced that Elborafﾮ (vemurafenib) was approved by the FDA for the treatment of…
Genentech drug Zelboraf (vemurafenib) was approved
On Aug. 16, 2011, the U.S. Food and Drug Administration (FDA) approved vemurafenib tablets (Zelboraf, Hoffmann-LaRoche Inc.) for…
FDA approved Boostrix to prevent tetanus, diphtheria, and pertussis in older people
On Jul. 8, 2011, the FDA approved Boostrix (Tdap, GlaxoSmithKline) to prevent tetanus, diphtheria, and pertussis in older…
FDA approved the first vaccine to prevent meningococcal disease in infants and toddlers
On Apr. 22, 2011, The U.S. Food and Drug Administration (FDA) approved the use of Menactra in children…
Zostavax was approved by the FDA to prevent shingles in individuals 50 years of age and older
On Mar. 24, 2011, Zostavax, manufactured by Merck of Whitehouse Station, New Jersey, was approved by the U.S….
Gilead Sciences acquired Calistoga Pharmaceuticals for $375 Million
On Feb. 22, 2011, Foster City, Calif-based Gilead Sciences and Calistoga Pharmaceuticals announced Gilead’s acquisition of Calistoga for…
FDA approved Gardasil HPV vaccine to include the indication for the prevention of anal cancer
On Dec. 22, 2010, the FDA approved Gardasil HPV vaccine to include the indication for the prevention of…
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 (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…