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…
Animal Drug Availability Act added flexibility to animal drug approval process
On Oct. 9, 1996, the Animal Drug Availability Act added flexibility to animal drug approval process, providing for…
Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed was licensed
On Jul. 31, 1996, the diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Tripedia by Aventis Pasteur)…
Topotecan (Hycamptin) was approved by the FDA for the treatment of metastatic ovarian cancer
On Jun. 14, 1996, topotecan (Hycamptin), the first of a class of drugs that interferes with the enzyme…
The Federal Tea Tasters Repeal Act was passed
On Apr. 9, 1996, the Federal Tea Tasters Repeal Act of 1996 eliminated the Board of Tea Experts…
Diagnostics | FDA | HIV | Life Science News
The FDA approved the first test for HIV antigen screening of blood donors
On Mar. 14, 1996, the U.S. Food and Drug Administration (FDA) announced the approval of the first antigen…
The FDA approved anastrozole (Arimidex) as a treatment for breast cancer
In January 1996, the U.S. Food and Drug Administration (FDA) approved anastrozole (Arimidex) as a treatment for breast…
The first genetically engineered crop was commercialized
In 1996, the first genetically engineered crop was commercialized. The first genetically modified plant was produced a short…
The FDA approved another topoisomerase 1 inhibitor for the treatment of metastatic colorectal cancer
In 1996, the U.S. Food and Drug Administration (FDA) approved another topoisomerase 1 inhibitor – irinotecan (Camptosar) –…
GeneChip was developed by Stanford University and Affymetrix
On Dec. 11, 1996, scientists from Stanford University and Affymetrix announced a new high-tech method that used a…
Genentech drug Nutropin AQ ((somatropin) injection for subcutaneous use) was approved
On Dec. 29, 1995, the Genentech drug Nutropin AQ ((somatropin) injection for subcutaneous use) was approved by the…
Saccharin Notice Repeal Act repealed the saccharin notice requirements
On Dec. 6, 1995, the U.S. Congress repealed the saccharin notice requirements. The store warning notice requirement was…
Genentech drug CellCept (mycophenolate mofetil) approved by FDA
On May 3, 1995, the U.S. Food & Drug Administration (FDA) announced it had approved Genentech’s drug CellCept…
The FDA approved tretinoin, a differentiating agent related to vitamin A, for use in the treatment of acute promyelocytic leukemia
In 1995, The U.S. Food and Drug Administration (FDA) approved tretinoin, a differentiating agent related to vitamin A,…
Porfimer sodium, a light-sensitive drug that can be absorbed by tumors, was approved by the FDA
In 1995, Porfimer sodium, a light-sensitive drug that can be absorbed by tumors, was approved by the FDA,…
FDA declared cigarettes to be “drug delivery devices”
In 1995, the FDA declared cigarettes to be “drug delivery devices.” Restrictions were proposed on marketing and sales…