Cialis was approved by the FDA
On Nov. 21, 2003, Cialis (tadalafil), discovered through a Glaxo Wellcome and ICOS Corp. partnership, was approved by…
An obesity working group is established by the Commissioner of Food and Drugs
On Oct. 8, 2003, an obesity working group was established by the Commissioner of Food and Drugs, charged…
FDA approved an expanded indication for ENBREL (etanercept) to inhibit progression of structural damage of active arthritis
On Aug. 25, 2003, the FDA approved an expanded indication for ENBREL (etanercept) to inhibit the progression of…
The FDA announced food labels to include trans fat content
On Jul. 11, 2003, the U.S. Food and Drug Administration (FDA) published a final rule in the Federal…
Genentech drug Xolair (omalizumab) was approved
On Jun. 20, 2003, Genentech drug Xolair (omalizumab) was approved by the U. S. Food and Drug Administration…
The FDA approved the drug bortezomib (Velcade) for the treatment of multiple myeloma
On May 13, 2003, the FDA approved the drug bortezomib (Velcade) for the treatment of multiple myeloma. In…
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The National Academy of Sciences released “Scientific Criteria to Ensure Safe Food”
On Apr. 7, 2003, the National Academy of Sciences released “Scientific Criteria to Ensure Safe Food,” a report…
Biotechnology | Disease | FDA | Life Science News | Medicine | Therapeutics
Long-term efficacy and safety of etanercept was found in children with polyarticular-course juvenile rheumatoid arthritis
On Jan. 10, 2003, long-term efficacy and safety of etanercept (Enbrel) was found in children with polyarticular-course juvenile…
The Animal Drug User Fee Act permits FDA to collect subsidies for the review of certain animal drug applications from sponsors
In 2003, The Animal Drug User Fee Act permits FDA to collect subsidies for the review of certain…
Two randomized controlled trials showed that taking aspirin daily for as little as three years reduces the development of colorectal polyps
In 2003, two randomized controlled trials showed that taking aspirin daily for as little as three years reduces…
The FDA Office of Combination Products was formed
On Dec. 24, 2002, the FDA’s Office of Combination Products was formed within the Office of the Commissioner,…
Vaccine that combined diphtheria, tetanus, acellular pertussis, inactivated polio and hepatitis B antigens was licensed
On Dec. 13, 2002, the U.S. Food and Drug Administration (FDA) announced it had licensed a combined diphtheria…
Genentech drug Pegasys (peginterferon alfa-2a) approved
On Dec. 3, 2002, Genentech drug Pegasys (peginterferon alfa-2a) was approved by the Food and Drug Administration (FDA)…
NCI and FDA scientists reported patterns of proteins found in patients’ blood can distinguish between prostate cancer and benign conditions
On Oct. 16, 2002, patterns of proteins found in patients’ blood may help distinguish between prostate cancer and…
FDA announced initiative to modernize the regulation of pharmaceutical manufacturing
On Aug. 21, 2002, the FDA announced an initiative to modernize the regulation of pharmaceutical manufacturing and product…
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…
Biotechnology | FDA | HIV | Life Science News | 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…