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Home / FDA - Page 28

FDA

Genentech drug Alecensa (alectinib) was approved by FDA
Biotechnology | Diagnostics | FDA | Therapeutics

Genentech drug Alecensa (alectinib) was approved by FDA

On Dec. 11, 2015, Genentech announced that it’s drug Alecensa (alectinib) was approved by the U.S. Food and…

Read More Genentech drug Alecensa (alectinib) was approved by FDAContinue

FDA approved new injectable influenza vaccine, Fluad, for use in people age 65 years and older
Biotechnology | FDA | Infectious Disease | Influenza | Vaccine

FDA approved new injectable influenza vaccine, Fluad, for use in people age 65 years and older

On Nov. 25, 2015, Seqirus announced that the U.S. Food and Drug Administration (FDA) had approved Fluad™ (Influenza…

Read More FDA approved new injectable influenza vaccine, Fluad, for use in people age 65 years and olderContinue

The FDA approved AquaBounty Technologies’ application to sell the AquAdvantage genetically engineered salmon
Biotechnology | FDA | Marine Science

The FDA approved AquaBounty Technologies’ application to sell the AquAdvantage genetically engineered salmon

On Nov. 19, 2015, AquaBounty Technologies announced the U.S. Food and Drug Administration (FDA) had approved the Company’s…

Read More The FDA approved AquaBounty Technologies’ application to sell the AquAdvantage genetically engineered salmonContinue

Genentech drug Cotellic (cobimetinib) was approved
Biotechnology | FDA | Therapeutics

Genentech drug Cotellic (cobimetinib) was approved

On Nov. 10, 2015, Genentech announed that its drug Cotellic (cobimetinib) was approved by the U.S. Food and…

Read More Genentech drug Cotellic (cobimetinib) was approvedContinue

CDC published updated ACIP recommendations regarding the intervals between PCV13 and PPSV23 vaccines
Biotechnology | CDC | FDA | NIH | Non-Profit Research | Pharmaceutical | Vaccine

CDC published updated ACIP recommendations regarding the intervals between PCV13 and PPSV23 vaccines

On Sept. 4, 2015, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices…

Read More CDC published updated ACIP recommendations regarding the intervals between PCV13 and PPSV23 vaccinesContinue

FDA approved injectable drug to eliminate double chin
Biotechnology | FDA | Therapeutics

FDA approved injectable drug to eliminate double chin

On Apr. 29, 2015, the U.S. Food and Drug Administration (FDA) announced it had approved Kybella, an injection…

Read More FDA approved injectable drug to eliminate double chinContinue

FDA approved the Quadracelᅠ DTaP+IPV ᅠvaccine for use in children age 4-6 years
Biotechnology | FDA | Vaccine

FDA approved the Quadracelᅠ DTaP+IPV ᅠvaccine for use in children age 4-6 years

On Mar. 24, 2015, the U.S. Food and Drug Administration (FDA) approved Sanofi’s Quadracel, a newᅠcombinationᅠDTaP+IPVᅠ vaccine for…

Read More FDA approved the Quadracelᅠ DTaP+IPV ᅠvaccine for use in children age 4-6 yearsContinue

The first biosimilar Zarxio (Filgrastim-sndz) was approved by the FDA
FDA | Life Science History

The first biosimilar Zarxio (Filgrastim-sndz) was approved by the FDA

On Mar. 6, 2015, the FDA approved filgrastim-sndz (Zarxio, Sandoz, Inc.), the first biosimilar product available in the…

Read More The first biosimilar Zarxio (Filgrastim-sndz) was approved by the FDAContinue

FDA approved the use of Bexsero, the second vaccine licensed in the U.S. to prevent serogroup B meningococcal disease
Biotechnology | Disease | FDA | Non-Profit Research | Therapeutics | Vaccine

FDA approved the use of Bexsero, the second vaccine licensed in the U.S. to prevent serogroup B meningococcal disease

On Jan. 23, 2015, Novartis announced the US Food and Drug Administration (FDA) had granted accelerated approval of…

Read More FDA approved the use of Bexsero, the second vaccine licensed in the U.S. to prevent serogroup B meningococcal diseaseContinue

FDA approved Novo Nordisk’s injection for obesity
FDA | Life Science History

FDA approved Novo Nordisk’s injection for obesity

On Dec. 23, 2014, Novo Nordisk the FDA approved a formulation of Novo Nordiskメs diabetes drug, liraglutide, for…

Read More FDA approved Novo Nordisk’s injection for obesityContinue

BioCryst’s RAPIVAB(TM) (peramivir injection) received FDA approval for treatment of influenza in adults
Biotechnology | FDA | Infectious Disease | Influenza | Pharmaceutical | Therapeutics

BioCryst’s RAPIVAB(TM) (peramivir injection) received FDA approval for treatment of influenza in adults

On Dec. 22, 2014, BioCryst Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) had approved RAPIVAB (peramivir…

Read More BioCryst’s RAPIVAB(TM) (peramivir injection) received FDA approval for treatment of influenza in adultsContinue

FDA approved the use of Gardasil 9 HPV vaccine in the US
FDA | Life Science History

FDA approved the use of Gardasil 9 HPV vaccine in the US

On Dec. 11, 2014, Merck announced that the FDA had approved GARDASILᆴ9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merckメs…

Read More FDA approved the use of Gardasil 9 HPV vaccine in the USContinue

FDA approved quadrivalent formulation of Fluzone Intradermal inactivated influenza vaccine
Biotechnology | FDA | Infectious Disease | Influenza | Vaccine

FDA approved quadrivalent formulation of Fluzone Intradermal inactivated influenza vaccine

On Dec. 12, 2014, Sanofi Pasteur announced the U.S. Food and Drug Administration (FDA) had approved the supplemental…

Read More FDA approved quadrivalent formulation of Fluzone Intradermal inactivated influenza vaccineContinue

FDA approved the use of Trumenba in the US to prevent serogroup B meningococcal disease
FDA | Life Science History

FDA approved the use of Trumenba in the US to prevent serogroup B meningococcal disease

On Oct. 29, 2014, Pfizer announced the FDA has granted accelerated approval of TRUMENBAᆴ (meningococcal group B vaccine)…

Read More FDA approved the use of Trumenba in the US to prevent serogroup B meningococcal diseaseContinue

Genentech drug Esbriet (pirfenidone) was approved
Biotechnology | FDA | Therapeutics

Genentech drug Esbriet (pirfenidone) was approved

On Oct. 15, 2014, Genentech drug Esbriet (pirfenidone) was approved by the U.S. Food and Drug Administration (FDA)…

Read More Genentech drug Esbriet (pirfenidone) was approvedContinue

CDC published ACIP recommendations for use of PCV13 and PPSV23 vaccines in adults age 65 and older
Biotechnology | Disease | FDA | NIH | Non-Profit Research | Pharmaceutical | Vaccine

CDC published ACIP recommendations for use of PCV13 and PPSV23 vaccines in adults age 65 and older

On Sept. 19, 2014, the Centers for Disease Control and Prevention”s (CDC) Advisory Committee on Immunization Practices (ACIP)…

Read More CDC published ACIP recommendations for use of PCV13 and PPSV23 vaccines in adults age 65 and olderContinue

FDA approved Genentech’s Avastin plus chemotherapy for treatment of advanced cervical cancer
Biotechnology | Chemical | FDA | Oncology | Therapeutics | Women's Health

FDA approved Genentech’s Avastin plus chemotherapy for treatment of advanced cervical cancer

On Aug. 14. 2014, Genentech announced that the U.S. Food and Drug Administration (FDA) had approved Avastin (bevacizumab)…

Read More FDA approved Genentech’s Avastin plus chemotherapy for treatment of advanced cervical cancerContinue

Omeros received FDA Approval of Omidria
Biotechnology | Disease | FDA | Therapeutics

Omeros received FDA Approval of Omidria

On Jun. 2, 2014, Omeros received U.S. Food and Drug Administration (FDA) approval of Omidria for use in…

Read More Omeros received FDA Approval of OmidriaContinue

FDA lowered age of licensure for Adacel vaccine administration from age 11 years to 10 years
FDA | Life Science History

FDA lowered age of licensure for Adacel vaccine administration from age 11 years to 10 years

On Apr. 1, 2014, Sanofi Pasteur announced the U.S. Food and Drug Administration (FDA) had expanded the approved…

Read More FDA lowered age of licensure for Adacel vaccine administration from age 11 years to 10 yearsContinue

Genentech drug Gazyva (obinutuzumab) was approved
Biotechnology | FDA | Oncology | Therapeutics

Genentech drug Gazyva (obinutuzumab) was approved

On Nov. 13, 2013, Genentech announced that it’s drug Gazyva (obinutuzumab) was approved by the U.S. Food and…

Read More Genentech drug Gazyva (obinutuzumab) was approvedContinue

FDA extended FluLaval IIV age range to include children and teens age 3ヨ17 years; licenses quadrivalent FluLaval product
FDA | Life Science History

FDA extended FluLaval IIV age range to include children and teens age 3ヨ17 years; licenses quadrivalent FluLaval product

On Aug. 16, 2013, the FDA extended FluLaval IIV (GlaxoSmithKline) age range to include children and teens age…

Read More FDA extended FluLaval IIV age range to include children and teens age 3ヨ17 years; licenses quadrivalent FluLaval productContinue

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

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