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Novartis’ meningitis B vaccine Bexsero approved by US FDA

Novartis’ meningitis B vaccine Bexsero approved by US FDA

24-01-2015

On Friday, the US Food and Drug Administration granted accelerated approval of Swiss pharma giant Novartis’…

BexseroNovartisPharmaceuticalRegulationUSAVaccines

The first Sabin IPV approved by China FDA

19-01-2015

The China Food and Drug Administration (CFDA) on January 14 approved the production of the first inactivated…

ChinaPharmaceuticalProductionRegulationVaccines

Sanofi Pasteur gains FDA approval of Fluzone Intradermal Quadrivalent for adults

Sanofi Pasteur gains FDA approval of Fluzone Intradermal Quadrivalent for adults

13-12-2014

French pharma major Sanofi’s vaccines division, Sanofi Pasteur, has received approval from the US Food…

Anti-viralsFluzonePharmaceuticalRegulationSanofiSanofi PasteurUSAVaccines

Merck’s new Gardasil 9 gains backing from US FDA

Merck’s new Gardasil 9 gains backing from US FDA

11-12-2014

The US Food and Drug Administration yesterday approved pharma giant Merck & Co’s Gardasil 9-valent…

Gardasil 9Merck & CoOncologyPharmaceuticalRegulationUSAVaccines

EMA committee concludes no evidence Fluad caused deaths

EMA committee concludes no evidence Fluad caused deaths

04-12-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that…

EuropeFluadNovartisPharmaceuticalRegulationVaccines

FTC puts conditions on GSK/Novartis consumer JV

27-11-2014

The US Federal Trade Commission has voted to approve UK pharma giant GlaxoSmithKline’s proposed acquisition…

Dr Reddy's LaboratoriesGlaxoSmithKlineHabitrolMergers & AcquisitionsNicodermNovartisPharmaceuticalRegulationUSAVaccines

US FDA approves first vaccine to prevent serogroup B meningococcal disease

30-10-2014

The US Food and Drug Administration yesterday granted accelerated approval for pharma major Pfizer’s…

PfizerPharmaceuticalRegulationTrumenbaUSAVaccines

EMA advises GlaxoSmithKline on Ebola vaccine development

29-10-2014

The European Medicines Agency has given scientific advice to UK pharma major GlaxoSmithKline on its development…

Anti-viralsGlaxoSmithKlinePharmaceuticalRegulationResearchVaccines

EMA moves further to push Ebola treatments development

EMA moves further to push Ebola treatments development

23-10-2014

During the past months, the European Medicines Agency has put in place a system to give the best possible…

Anti-viralsEuropePharmaceuticalRegulationResearchVaccines

IMS Health identifies 10 events that may transform the delivery of health care

IMS Health identifies 10 events that may transform the delivery of health care

23-09-2014

As the global market for drugs surpasses $1 trillion this year, growing payer scrutiny of value for money…

Anti-viralsFinancialGlobalHealthcarePharmaceuticalRegulationResearchVaccines

Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

15-08-2014

The US Food and Drug Administration has accepted for review the Biologics License Application for bivalent…

Invasive meningococcal diseaseLP2086PfizerPharmaceuticalRegulationrLP2086USAVaccines

GSK files EU regulatory submission for RTS,S malaria vaccine candidate

24-07-2014

UK pharma giant GlaxoSmithKline announced today that it has submitted a regulatory application to the…

EuropeGlaxoSmithKlinePharmaceuticalRegulationRest of the WorldRTS,STropical diseasesVaccines

FDA approval for Protein Sciences’ 2014/15 formulation of Flublok

FDA approval for Protein Sciences’ 2014/15 formulation of Flublok

09-07-2014

The US Food and Drug Administration has approved privately-held US biotech firm Protein Sciences’ strain…

BiotechnologyFlublokInfluenzaProtein Sciences CorpRegulationUSAVaccines

Positive WHO assessment of China’s vaccines regulatory authority

Positive WHO assessment of China’s vaccines regulatory authority

06-07-2014

China's national vaccine supervision system has met or passed all the standard requirements of the World…

ChinaPharmaceuticalRegulationVaccines

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

04-07-2014

Japanese drug major Mitsubishi Tanabe Pharma has received approval to manufacture and market the SGLT2…

canagliflozinCanagluDaiichi SankyoDiabetesJapanMitsubishi TanabePharmaceuticalRegulationSanofi PasteurVaccines

Novartis files for US approval of meningitis B vaccine Bexsero

Novartis files for US approval of meningitis B vaccine Bexsero

17-06-2014

Swiss pharma major Novartis has submitted a Biologic License Application to the US Food and Drug Administration…

BexseroBiotechnologyNovartisRegulationUSAVaccines

FDA licenses Novartis facility to produce cell-culture influenza vaccines

FDA licenses Novartis facility to produce cell-culture influenza vaccines

16-06-2014

The US Food and Drug Administration has licensed Swiss pharma major Novartis’ manufacturing facility…

FlucelvaxNovartisPharmaceuticalProductionRegulationUSAVaccines

UK about turn, as JCVI now recommends meningitis B vaccination for infants

21-03-2014

The UK’s Joint Committee on Vaccination and Immunization has recommended that the meningitis B vaccine…

BexseroNorthern EuropeNovartisPharmaceuticalRegulationUKVaccines

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

20-03-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to pharma behemoth Pfizer’s…

North AmericaPfizerPharmaceuticalRegulationrLP2086USAVaccines

Pharma Summit: Merck’s European president Bruno Strigini highlights importance of innovation

Pharma Summit: Merck’s European president Bruno Strigini highlights importance of innovation

17-03-2014

The president of pharma giant Merck & Co’s (NYSE: MRK) operations in Europe and Canada Bruno Strigini…

Anti-viralsCanadaDiabetesEuropeInterviewsMerck & CoMK-3475OncologyPharmaceuticalRegulationUKVaccines

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

27-02-2014

Despite citing the need for further safety studies, both US and EU regulators have lauded the immunogenicity…

Anti-viralsBiotechnologyDynavax TechnologiesHeplisavRegulationResearchVaccines

Dynavax withdraws European MAA for Heplisav

18-02-2014

US biotech firm Dynavax Technologies says it has withdrawn the European Marketing Authorization Application…

Anti-viralsBiotechnologyDynavax TechnologiesEuropeHeplisavRegulationVaccines

China bans BioKangtai hepatitis B vaccine

26-12-2013

Chinese authorities on Friday issued a circular to ban the use of the recombinant hepatitis B vaccine…

Anti-viralsAsia-PacificBioKangtaiChinaHealthcarePharmaceuticalRegulationVaccines

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