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Home / FDA - Page 29

FDA

FDA expanded age indication for Menveo to include infants and toddlers age 2 through 23 months
Biotechnology | FDA | Vaccine

FDA expanded age indication for Menveo to include infants and toddlers age 2 through 23 months

On Aug. 1, 2013, Novartis announced the U.S. Food and Drug Administration (FDA) had approved Menveo (Meningococcal [Groups…

Read More FDA expanded age indication for Menveo to include infants and toddlers age 2 through 23 monthsContinue

FDA approved Fluzone as the third quadrivalent influenza vaccine licensed for US use
Biotechnology | FDA | Infectious Disease | Influenza | Vaccine

FDA approved Fluzone as the third quadrivalent influenza vaccine licensed for US use

On Jun. 10, 2013, Sanofi Pasteur announced the U.S. Food and Drug Administration (FDA) had approved the supplemental…

Read More FDA approved Fluzone as the third quadrivalent influenza vaccine licensed for US useContinue

Genentech drug Kadcyla (ado-trastuzumab emtansine) was approved
Biotechnology | Diagnostics | Disease | FDA | Oncology | Therapeutics

Genentech drug Kadcyla (ado-trastuzumab emtansine) was approved

On Feb. 22, 2013,  the U.S. Food and Drug Administration (FDA) announced they had approved Genentech’s licensed ado-trastuzumab…

Read More Genentech drug Kadcyla (ado-trastuzumab emtansine) was approvedContinue

FDA approved use of Prevnar 13 vaccine in older children and teens (6-17 years)
FDA | Life Science History

FDA approved use of Prevnar 13 vaccine in older children and teens (6-17 years)

On Jan. 25, 2013, Pfizer announced the FDA had granted approval for the expansion of the companyメs pneumococcal…

Read More FDA approved use of Prevnar 13 vaccine in older children and teens (6-17 years)Continue

FDA approved quadrivalent formulation of Fluarix
Biotechnology | FDA | Influenza | Vaccine

FDA approved quadrivalent formulation of Fluarix

On Dec. 14, 2012, the U.S. Food and Drug Administration (FDA) announced it had approved GlaxoSmithKline’s quadrivalent formulation…

Read More FDA approved quadrivalent formulation of FluarixContinue

FDA approved first seasonal influenza vaccine manufactured using cell culture technology
Biotechnology | FDA | Influenza | Vaccine

FDA approved first seasonal influenza vaccine manufactured using cell culture technology

On Nov. 20, 2012, the U.S. Food and Drug Administration (FDA) announced it had approved first seasonal influenza…

Read More FDA approved first seasonal influenza vaccine manufactured using cell culture technologyContinue

Lucentis approved for treatment of diabetic macular edema
Biotechnology | FDA | Life Science History | Ophthalmogy

Lucentis approved for treatment of diabetic macular edema

On Aug. 10. 2012, Genentech announced that Lucentis (ranibizumab injection) was approved by the U.S. Food and Drug…

Read More Lucentis approved for treatment of diabetic macular edemaContinue

The FDA’s “Breakthrough Therapy Designation” was created
Biotechnology | Disease | FDA | Life Science History | Therapeutics

The FDA’s “Breakthrough Therapy Designation” was created

On Jul. 9, 2012, the FDA created the “Breakthrough Therapy Designation” that expedites development and review of drugs…

Read More The FDA’s “Breakthrough Therapy Designation” was createdContinue

FDA approved HibMenCY vaccine for infants
Biotechnology | Disease | FDA | Vaccine

FDA approved HibMenCY vaccine for infants

On Jun. 24, 2012, the U.S. Food and Drug Administration (FDA) announced it had approved HibMenCY (Menhibrix, GlaxoSmithKline),…

Read More FDA approved HibMenCY vaccine for infantsContinue

Genentech drug Perjeta (pertuzumab) was approved
Biotechnology | Disease | FDA | Oncology | Therapeutics | Women's Health

Genentech drug Perjeta (pertuzumab) was approved

On Jun. 8, 2012, the U.S. Food and Drug Administration (FDA) announced that Genentech’s drug Perjeta (pertuzumab) was…

Read More Genentech drug Perjeta (pertuzumab) was approvedContinue

FDA expanded licensure of PCV13 to include adults ages 50 years and older
FDA | Life Science History

FDA expanded licensure of PCV13 to include adults ages 50 years and older

On Jun. 7, 2012, the FDA expanded licensure of PCV13 for prevention of pneumococcal disease to include adults…

Read More FDA expanded licensure of PCV13 to include adults ages 50 years and olderContinue

FDA approved orphan drug Elelyso to treat a form of Gaucher disease
Biotechnology | Disease | FDA | Therapeutics

FDA approved orphan drug Elelyso to treat a form of Gaucher disease

On May 1, 2012, the U.S. Food and Drug Administration (FDA) approved new orphan drug Elelyso to treat…

Read More FDA approved orphan drug Elelyso to treat a form of Gaucher diseaseContinue

The FDA approved Korlym for patients with endogenous Cushing’s syndrome
Biotechnology | Disease | FDA | Therapeutics

The FDA approved Korlym for patients with endogenous Cushing’s syndrome

On Feb. 17, 2012, the FDA announced Korlym (mifepristone) was approved to control high blood sugar levels (hyperglycemia)…

Read More The FDA approved Korlym for patients with endogenous Cushing’s syndromeContinue

The FDA approved Gleevec for Five Rare, Life-Threatening Disorders
Biotechnology | FDA | Non-Profit Research | Oncology | Therapeutics

The FDA approved Gleevec for Five Rare, Life-Threatening Disorders

On Jan. 31, 2012, the U.S. Food and Drug Administration (FDA) granted Gleevec (imatinib) regular approval for use…

Read More The FDA approved Gleevec for Five Rare, Life-Threatening DisordersContinue

The FDA approved KALYDECO (ivacaftor) a University of Washington-tested drug to treat the genetic mechanism of cystic fibrosis
Biotechnology | FDA | Therapeutics

The FDA approved KALYDECO (ivacaftor) a University of Washington-tested drug to treat the genetic mechanism of cystic fibrosis

On Jan. 31, 2012, the FDA approved a KALYDECO (ivacaftor), University of Washington-tested drug to treat the genetic…

Read More The FDA approved KALYDECO (ivacaftor) a University of Washington-tested drug to treat the genetic mechanism of cystic fibrosisContinue

The U.S. FDA approved Erivedge (vismodegib) capsule, the first medicine for adults with advanced basal cell carcinoma
Biotechnology | FDA | Oncology | Therapeutics

The U.S. FDA approved Erivedge (vismodegib) capsule, the first medicine for adults with advanced basal cell carcinoma

On Jan. 30, 2012, the U.S. Food and Drug Administration (FDA) approved Genentech’s Erivedge (vismodegib) capsule, the first…

Read More The U.S. FDA approved Erivedge (vismodegib) capsule, the first medicine for adults with advanced basal cell carcinomaContinue

FDA expanded use of Prevnar 13 vaccine to include people ages 50 and older
Biotechnology | FDA | Influenza | Vaccine

FDA expanded use of Prevnar 13 vaccine to include people ages 50 and older

On Dec. 30, 2011, Pfizer announced that the U.S. Food and Drug Administration (FDA) had granted approval of…

Read More FDA expanded use of Prevnar 13 vaccine to include people ages 50 and olderContinue

Addition of history of intussusception as a contraindication for rotavirus vaccination
FDA | Life Science History

Addition of history of intussusception as a contraindication for rotavirus vaccination

On Oct. 21, 2011, the Food and Drug Administration (FDA) announced it had approved revised prescribing information and…

Read More Addition of history of intussusception as a contraindication for rotavirus vaccinationContinue

The FDA approved Seattle Genetics’ Adcetris (brentuximab vedotin)
Disease | FDA | Oncology

The FDA approved Seattle Genetics’ Adcetris (brentuximab vedotin)

On Aug. 19, 2011, the U.S. Food and Drug Administration (FDA) approved Seattle Genetics’ Adcetris (brentuximab vedotin), making…

Read More The FDA approved Seattle Genetics’ Adcetris (brentuximab vedotin)Continue

Genentech medicine approved for certain type of melanoma
FDA | Life Science History

Genentech medicine approved for certain type of melanoma

On Aug. 17, 2011, Genentech announced that Elborafᆴ (vemurafenib) was approved by the FDA for the treatment of…

Read More Genentech medicine approved for certain type of melanomaContinue

Genentech drug Zelboraf (vemurafenib) was approved
Biotechnology | FDA | Life Science History | Oncology | Therapeutics

Genentech drug Zelboraf (vemurafenib) was approved

On Aug. 16, 2011, the U.S. Food and Drug Administration (FDA) approved vemurafenib tablets (Zelboraf, Hoffmann-LaRoche Inc.) for…

Read More Genentech drug Zelboraf (vemurafenib) was approvedContinue

FDA approved Boostrix to prevent tetanus, diphtheria, and pertussis in older people
FDA | Life Science History

FDA approved Boostrix to prevent tetanus, diphtheria, and pertussis in older people

On Jul. 8, 2011, the FDA approved Boostrix (Tdap, GlaxoSmithKline) to prevent tetanus, diphtheria, and pertussis in older…

Read More FDA approved Boostrix to prevent tetanus, diphtheria, and pertussis in older peopleContinue

FDA approved the first vaccine to prevent meningococcal disease in infants and toddlers
Biotechnology | FDA | Infectious Disease | Neurology | Vaccine

FDA approved the first vaccine to prevent meningococcal disease in infants and toddlers

On Apr. 22, 2011, The U.S. Food and Drug Administration (FDA) approved the use of Menactra in children…

Read More FDA approved the first vaccine to prevent meningococcal disease in infants and toddlersContinue

Zostavax was approved by the FDA to prevent shingles in individuals 50 years of age and older
FDA | Life Science History

Zostavax was approved by the FDA to prevent shingles in individuals 50 years of age and older

On Mar. 24, 2011, Zostavax, manufactured by Merck of Whitehouse Station, New Jersey, was approved by the U.S….

Read More Zostavax was approved by the FDA to prevent shingles in individuals 50 years of age and olderContinue

Gilead Sciences acquired Calistoga Pharmaceuticals for $375 Million
Biotechnology | FDA | Life Science History | Oncology | Pharmaceutical | Therapeutics

Gilead Sciences acquired Calistoga Pharmaceuticals for $375 Million

On Feb. 22, 2011, Foster City, Calif-based Gilead Sciences and Calistoga Pharmaceuticals announced Gilead’s acquisition of Calistoga for…

Read More Gilead Sciences acquired Calistoga Pharmaceuticals for $375 MillionContinue

FDA approved Gardasil HPV vaccine to include the indication for the prevention of anal cancer
FDA | Life Science History

FDA approved Gardasil HPV vaccine to include the indication for the prevention of anal cancer

On Dec. 22, 2010, the FDA approved Gardasil HPV vaccine to include the indication for the prevention of…

Read More FDA approved Gardasil HPV vaccine to include the indication for the prevention of anal cancerContinue

PROVENGE was approved by the FDA
Biotechnology | FDA | Therapeutics

PROVENGE was approved by the FDA

On Apr. 29, 2010, the FDA approved sipuleucel-T (PROVENGE), made by the Dendreon Corp., an autologous cellular immunotherapy…

Read More PROVENGE was approved by the FDAContinue

FDA recommended physicians suspend use of GSK’s Rotarix rotavirus vaccine due to porcine circovirus 1 contamination
Biotechnology | FDA | Infectious Disease | Vaccine

FDA recommended physicians suspend use of GSK’s Rotarix rotavirus vaccine due to porcine circovirus 1 contamination

On Mar. 23, 2010, the U.S. Food and Drug Administration (FDA) recommended that physicians temporarily suspend use of…

Read More FDA recommended physicians suspend use of GSK’s Rotarix rotavirus vaccine due to porcine circovirus 1 contaminationContinue

FDA approved licensure of Pneumococcal 13-valent conjugate vaccine
Biotechnology | FDA | Infectious Disease | Vaccine

FDA approved licensure of Pneumococcal 13-valent conjugate vaccine

On Feb. 24, 2010, a 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals, a subsidiary of Pfizer])…

Read More FDA approved licensure of Pneumococcal 13-valent conjugate vaccineContinue

FDA approved licensure of Menveo (Novartis), meningococcal conjugate vaccine
Biotechnology | FDA | Infectious Disease | Vaccine

FDA approved licensure of Menveo (Novartis), meningococcal conjugate vaccine

On Feb. 19, 2010, the U.S. Food and Drug Administration (FDA) announced it had licensed a quadrivalent meningococcal…

Read More FDA approved licensure of Menveo (Novartis), meningococcal conjugate vaccineContinue

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