Biotechnology | FDA | Medicine | Therapeutics
The acquisition of Immunex by Amgen for $16 billion was announced
On Dec. 17, 2001, the acquisition of Immunex by Amgen was announced for $16 billion in stock and…
Biotechnology | Disease | FDA | Therapeutics
Genentech drug Cathflo Activase (alteplase) was approved
On Sept. 13, 2001, the Food and Drug Administration (FDA) announced it had approved Genentech’s request for it’s…
The FDA approved Gleevec, developed by OHSU, for treatment of chronic myeloid leukemia
On May 10, 2001, the U.S. Food and Drug Administration (FDA) approved Gleevec, the world’s first targeted cancer…
Biotechnology | FDA | HIV | Therapeutics
Genentech drug Valcyte (valganciclovir hydrochloride) was approved
On Mar. 29, 2001, the Food and Drug Administration (FDA) announced it had approved Genentech’s drug Valcyte (valganciclovir…
Corus Pharma was incorporated
On Jan. 12, 2001, Corus Pharma was incorporated as a private venture-backed development stage biopharmaceutical company focused on…
SynCardia Systems was founded
In 2001, SynCardia Systems, a private company formed to commercialize the Jarvik 7 artificial heart, was founded by…
Pathogenesis was acquired by Chiron for $660 million
On Sept. 22, 2000, Pathogenesis was acquired by Emeryville, California-based Chiron for $660 million or $38.50 per share….
Disease | FDA | Oncology | U.S. Congress
The Supreme Court ruled the FDA does not have authority to regulate tobacco as a drug
On Mar. 21, 2000, the Supreme Court ruled 5 to 4 along ideological lines, that the U.S. Food…
Eli Lilly and Takeda Chemical Industries launched Actos, an oral antidiabetes agent
In 2000, Eli Lilly and Takeda Chemical launched Actos, an oral anti diabetes agent. In 2005, a PROactive…
Biotechnology | FDA | Oncology | Therapeutics
FDA approved Targretin to treat certain T-cell lymphomas
On Dec. 29, 1999, the U.S. Food and Drug Administration (FDA) approved Bexarotene (Targretin) to treat cutaneous T-cell…
Diphtheria and tetanus toxoids and acellular pertussis vaccine was licensed
On Dec. 9, 1999, the diphtheria and tetanus toxoids and acellular pertussis vaccine (Tripedia by Connaught) was licensed….
The FDA approved LASIK corrective eye surgery
On Nov. 15, 1999, the FDA approved LASIK corrective eye surgery. LASIK stands for Laser-Assisted In Situ Keratomileusis…
FDA approved a 2-dose schedule of hepatitis B vaccination for adolescents
On Aug. 29, 1999, Merck, West Point, Pennsylvania) received approval from the FDA of a supplement to Merck’s…
Eli Lilly and Company’s Effient approved by the FDA for the reduction of thrombotic cardiovascular events
On Jul. 11, 1999, Daiichi Sankyo and Eli Lilly announced the FDA approved Effientﾙ(prasugrel) tablets for the reduction…
ZymoGenetics was instrumental in development of new hemophilia drug
On Mar. 27, 1999, Novo Nordisk, the ZymoGenetics parent company, announced approval of NovoSeven by the Food and…
Rule publication defined dietary supplements labeling
On Mar. 23, 1999, the Food and Drug Administration (FDA) announced a rule publication that defined dietary supplements…
The FDA mandated OTC drugs labels contain information in a standardized, consumer-friendly format
On Mar. 17, 1999, the Food and Drug Administration (FDA) published a regulation mandating that labels of all…
The Hybrid Capture II human papillomavirus (HPV) DNA test was approved by the FDA
On Mar. 17, 1999, the Hybrid Capture II human papillomavirus (HPV) DNA test was approved by the U.S….
Jane E Henney, MD, becomes the first woman Commissioner of Food and Drugs
On Jan. 17, 1999, Jane E. Henney, M.D., appointed by President Bill Clinton, became the first woman to…
Biotechnology | CDC | FDA | Infectious Disease | Vaccine
ACIP recommended DTaP vaccines for all five doses in the vaccination schedule
On Jan. 15. 1999, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices…
Biotechnology | Diagnostics | Disease | FDA | HIV | Therapeutics
Western Blot positive HIV tests done since Jan 1, 1999 became reportable by Texas State Law
On Jan. 1, 1999, HIV infection in adults (clients 13 years of age or older) became reportable by…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Therapeutics | Women's Health
The FDA approved the monoclonal antibody Herceptin (Trastuzumab) for treatment of metastatic breast cancer
On Sept. 25, 1998, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody Herceptin (Trastuzumab) for…
Rotavirus vaccine, live, oral, tetravalent was licensed
On Aug. 31, 1998, Rotashield (Wyeth Laboratories, Marietta, Pennsylvania) was licensed by the U.S. Food and Drug Administration…
Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Certiva by North American Vaccine) was licensed
On Jul. 29, 1998, the diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Certiva by North American…
Biotechnology | FDA | Oncology | Therapeutics
The FDA approved Genentech drug Xeloda (capecitabine)
On April 30, 1998, the U.S. Food and Drug Administration (FDA) approved the Genentech’s drug Xeloda (capecitabine) for…
The drug Viagra (Sildenafil) approved by the FDA
On Mar. 27, 1998. the Pfizer drug Viagra (Sildenafil) was approved by the FDA to treat erectile dysfunction….
First phase to consolidated FDA laboratories nationwide
In 1998, the first phase to consolidate U.S. Food and Drug Administration (FDA) laboratories nationwide from 19 facilities…
Biotechnology | Diagnostics | Disease | FDA | Therapeutics | U.S. Congress
FDA promulgated the Pediatric Rule
In 1998, the Pediatric Rule was implemented that required drug manufacturers to study the efficacy and safety of…
Immunex received FDA approval to market Enbrel for treatment of moderate to severe rheumatoid arthritis
On Nov. 10, 1998, Immunex announced that ENBREL(tm) (etanercept) had received approval from the U.S. Food and Drug…
Biotechnology | Disease | FDA | Oncology | Therapeutics
Monoclonal antibody rituximab (Rituxan) approved by the FDA to treat patients with non-Hodgkin lymphoma
On Nov. 26, 1997, the U.S. Food and Drug Administration (FDA) announced it had approved the Monoclonal antibody…