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….
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 FDA does…
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…
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 Effientï¾™(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…
Biotechnology | Diagnostics | FDA | Life Science News | Pharmaceutical | Therapeutics | U.S. Congress
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…
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 | FDA | HIV | Life Science News | 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…
The Hybrid Capture II human papillomavirus (HPV) DNA test is approved by the FDA
In 1999, The Hybrid Capture II human papillomavirus (HPV) DNA test was approved by the FDA as a…
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…
Biotechnology | Disease | FDA | Life Science News | Medicine
Genentech drug Herceptin (trastuzumab) was approved
On Sept. 25, 1998, the Genentech drug Herceptin (trastuzumab) was approved by the FDA Genentech drug Herceptin (trastuzumab)…
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…
The FDA approved Genentech drug Xeloda (capecitabine)
On April 30, 1998, the Food and Drug Administration (FDA) approved the Genentech’s drug Xeloda (capecitabine) for the…
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…
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 | Life Science News | 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…
The FDA Modernization Act was signed into law
On Nov. 21, 1997, the FDA Modernization Act (FDAMA) was signed into law, amending the Food, Drug and…
Rabies vaccine (RabAvert by Chiron Behring) was licensed
On Oct. 20, 1997, the Food and Drug Administration (FDA) licensed Purified Chick Embryo Cell (PCEC, RabAvert®) vaccine…
The U.S. FDA approved direct to consumer advertising
On Aug. 9, 1997, the U.S. Food and Drug Administration (FDA) announced a policy that allowed pharmaceutical companies…
Diphtheria and tetanus toxoids and acellular pertussis vaccine was licensed
On Dec. 30, 1996, the Food and Drug Administration (FDA) announced it had licensed three DTaP vaccines for…