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Home / FDA - Page 32

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NCI and FDA scientists reported patterns of proteins found in patients’ blood can distinguish between prostate cancer and benign conditions
Biotechnology | Diagnostics | FDA | Life Science History | Oncology

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…

Read More NCI and FDA scientists reported patterns of proteins found in patients’ blood can distinguish between prostate cancer and benign conditionsContinue

FDA announced initiative to modernize the regulation of pharmaceutical manufacturing
FDA | Life Science History

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…

Read More FDA announced initiative to modernize the regulation of pharmaceutical manufacturingContinue

The FDA announced the current good manufacturing practice (cGMP) initiative
FDA | Life Science History

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…

Read More The FDA announced the current good manufacturing practice (cGMP) initiativeContinue

FDA approved Amgen’s aranesp for anemia associated with chemotherapy
Biotechnology | FDA | Oncology | Therapeutics

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…

Read More FDA approved Amgen’s aranesp for anemia associated with chemotherapyContinue

Immunex Corp. was acquired by Amgen
Biotechnology | FDA | Therapeutics

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…

Read More Immunex Corp. was acquired by AmgenContinue

President Bush signed the Public Health Security and Bioterrorism Preparedness and Response Act into law
Biotechnology | Diagnostics | FDA | Infectious Disease | Medicine | NIH | Plague | Radiology | Therapeutics | U.S. Congress

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…

Read More President Bush signed the Public Health Security and Bioterrorism Preparedness and Response Act into lawContinue

Diphtheria and tetanus toxoids and acellular pertussis vaccine (Daptacel by Aventis Pasteur) was licensed
FDA | Infectious Disease | Vaccine

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…

Read More Diphtheria and tetanus toxoids and acellular pertussis vaccine (Daptacel by Aventis Pasteur) was licensedContinue

BOTOX(R) cosmetic (onabotulinumtoxinA) approved by the FDA
Biotechnology | FDA | Therapeutics

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…

Read More BOTOX(R) cosmetic (onabotulinumtoxinA) approved by the FDAContinue

The FDA approved the first nucleic acid test system to screen whole blood donors for infections with HIV and HCV
FDA | HIV | Life Science History

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…

Read More The FDA approved the first nucleic acid test system to screen whole blood donors for infections with HIV and HCVContinue

Scientists from NCI and FDA reported that patterns of proteins found in patients’ serum may reflect the presence of ovarian cancer
Biotechnology | Diagnostics | FDA | Oncology | Women's Health

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)…

Read More Scientists from NCI and FDA reported that patterns of proteins found in patients’ serum may reflect the presence of ovarian cancerContinue

FDA approved Gleevec for gastrointestinal stromal tumors treatment
Biotechnology | FDA | Non-Profit Research | Oncology | Therapeutics

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…

Read More FDA approved Gleevec for gastrointestinal stromal tumors treatmentContinue

The Best Pharmaceuticals for Children Act improved safety and efficacy of patented and off-patent medicines for children
Diagnostics | FDA | Medicine | Pharmaceutical | Therapeutics

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…

Read More The Best Pharmaceuticals for Children Act improved safety and efficacy of patented and off-patent medicines for childrenContinue

The acquisition of Immunex by Amgen for $16 billion was announced
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…

Read More The acquisition of Immunex by Amgen for $16 billion was announcedContinue

Genentech drug Cathflo Activase (alteplase) was approved
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…

Read More Genentech drug Cathflo Activase (alteplase) was approvedContinue

The FDA approved Gleevec, developed by OHSU, for treatment of chronic myeloid leukemia
Biotechnology | FDA | Non-Profit Research | Oncology | Therapeutics

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…

Read More The FDA approved Gleevec, developed by OHSU, for treatment of chronic myeloid leukemiaContinue

Genentech drug Valcyte (valganciclovir hydrochloride) was approved
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…

Read More Genentech drug Valcyte (valganciclovir hydrochloride) was approvedContinue

Corus Pharma was incorporated
Biotechnology | Disease | FDA | Pharmaceutical | Therapeutics

Corus Pharma was incorporated

On Jan. 12, 2001, Corus Pharma was incorporated as a private venture-backed development stage biopharmaceutical company focused on…

Read More Corus Pharma was incorporatedContinue

SynCardia Systems was founded
FDA | Medical Device | Therapeutics

SynCardia Systems was founded

In 2001, SynCardia Systems, a private company formed to commercialize the Jarvik 7 artificial heart, was founded by…

Read More SynCardia Systems was foundedContinue

Pathogenesis was acquired by Chiron for $660 million
Biotechnology | Disease | FDA | Life Science History | Therapeutics

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….

Read More Pathogenesis was acquired by Chiron for $660 millionContinue

The Supreme Court ruled the FDA does not have authority to regulate tobacco as a drug
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…

Read More The Supreme Court ruled the FDA does not have authority to regulate tobacco as a drugContinue

Eli Lilly and Takeda Chemical Industries launched Actos, an oral antidiabetes agent
Biotechnology | FDA | Therapeutics

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…

Read More Eli Lilly and Takeda Chemical Industries launched Actos, an oral antidiabetes agentContinue

FDA approved Targretin to treat certain T-cell lymphomas
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…

Read More FDA approved Targretin to treat certain T-cell lymphomasContinue

Diphtheria and tetanus toxoids and acellular pertussis vaccine was licensed
Biotechnology | FDA | Infectious Disease | Vaccine

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….

Read More Diphtheria and tetanus toxoids and acellular pertussis vaccine was licensedContinue

The FDA approved LASIK corrective eye surgery
FDA | Life Science History

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…

Read More The FDA approved LASIK corrective eye surgeryContinue

FDA approved a 2-dose schedule of hepatitis B vaccination for adolescents
FDA | Life Science History

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…

Read More FDA approved a 2-dose schedule of hepatitis B vaccination for adolescentsContinue

Eli Lilly and Company’s Effient approved by the FDA for the reduction of thrombotic cardiovascular events
FDA | Life Science History

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…

Read More Eli Lilly and Company’s Effient approved by the FDA for the reduction of thrombotic cardiovascular eventsContinue

ZymoGenetics was instrumental in development of new hemophilia drug
Biotechnology | Disease | FDA | Pharmaceutical | Therapeutics

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…

Read More ZymoGenetics was instrumental in development of new hemophilia drugContinue

Rule publication defined dietary supplements labeling
FDA | Therapeutics

Rule publication defined dietary supplements labeling

On Mar. 23, 1999, the Food and Drug Administration (FDA) announced a rule publication that defined dietary supplements…

Read More Rule publication defined dietary supplements labelingContinue

The FDA mandated OTC drugs labels contain information in a standardized, consumer-friendly format
FDA

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…

Read More The FDA mandated OTC drugs labels contain information in a standardized, consumer-friendly formatContinue

The Hybrid Capture II human papillomavirus (HPV) DNA test was approved by the FDA
Biotechnology | Diagnostics | FDA | Infectious Disease | Life Science History

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….

Read More The Hybrid Capture II human papillomavirus (HPV) DNA test was approved by the FDAContinue

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