The FDA announced the current good manufacturing practice (cGMP) initiative
On Aug. 21, 2002, the FDA announced an effort to enhance and update the regulation of manufacturing processes…
FDA approved Amgen’s aranesp for anemia associated with chemotherapy
On Jul. 22, 2002, Amgen announced that the U.S. Food and Drug Administration (FDA) had approved Aranesp (darbepoetin…
Immunex Corp. was acquired by Amgen
On Jul. 16, 2002, Amgen completed it’s acquisition of Immunex Corporation for $16 billion in stock and net…
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President Bush signed the Public Health Security and Bioterrorism Preparedness and Response Act into law
On Jun. 12, 2002, President George W. Bush signed the Public Health Security and Bioterrorism Preparedness and Response…
Diphtheria and tetanus toxoids and acellular pertussis vaccine (Daptacel by Aventis Pasteur) was licensed
On May 14, 2002, the Food and Drug Administration (FDA) approved for use an additional combined diphtheria and…
BOTOX(R) cosmetic (onabotulinumtoxinA) approved by the FDA
On Apr. 15, 2002, BOTOX(R) cosmetic (onabotulinumtoxinA), manufactured by Allergan, was approved by the Food and Drug Administration…
The FDA approved the first nucleic acid test system to screen whole blood donors for infections with HIV and HCV
On Feb. 28, 2002, the FDA announced it had licensed the first nucleic acid test (NAT) system intended…
Scientists from NCI and FDA reported that patterns of proteins found in patients’ serum may reflect the presence of ovarian cancer
On Feb. 7, 2002, scientists from the National Cancer Institute (NCI) and the Food and Drug Administration (FDA)…
FDA approved Gleevec for gastrointestinal stromal tumors treatment
On Feb. 1, 2002, the U.S. Food and Drug Administration (FDA) approved the drug Gleevec, formerly known as…
The Best Pharmaceuticals for Children Act improved safety and efficacy of patented and off-patent medicines for children
In 2002, the U.S. Congress passed the Best Pharmaceuticals for Children Act that improved safety and efficacy of…
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…
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…
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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….
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…
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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…
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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…