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US FDA clears GlaxoSmithKline’s H5N1 flu vaccine


The US Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s pandemic Influenza…

GlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year


Merck & Co yesterday provided an overview of the clinical trial program for V503, the company’s investigational…

Merck & CoNorth AmericaPharmaceuticalRegulationResearchV503Vaccines

GSK's Flulaval vaccine approved by US FDA


UK pharma giant GlaxoSmithKline (LSE: GSK) has had its Flulaval quadrivalent intramuscular influenza…

FluarixFlulavalGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

US FDA approves shipment of quadrivalent flu vaccine to health care providers


The US subsidiary of UK pharma giant GlaxoSmithKline (LSE: GSK) says it has received Food and Drug Administration…

Anti-viralsFluarixGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

FDA expands age indication for Menveo, quadrivalent meningococcal vaccine


The US Food and Drug Administration late yesterday (August 1) approved Swiss drug major Novartis' (NOVN:…

MenveoNorth AmericaNovartisPharmaceuticalRegulationVaccines

Negative FDA news for AVEO's tivozanib and Dynavax' hep B vaccine


US biotech firm AVEO Oncology (Nasdaq: AVEO) says that it has received a complete response letter from…

Anti-viralsAstellas PharmaAVEO OncologyBiotechnologyDynavax TechnologiesHeplisavNorth AmericaOncologyPharmaceuticalRegulationtivozanibVaccines

GlaxoSmithKline cleared for $91M flu vaccine plant in USA; Gets CRL on Q-Plan H5N1


UK pharma giant GlaxoSmithKline (LSE: GSK) and The Texas A&M University System (TAMUS) say that the US…

GlaxoSmithKlineNorth AmericaPharmaceuticalProductionQ-Plan H5N1RegulationVaccines

FDA delays approval of Dynavax' Heplisav, issuing CRL


Dynavax Technologies ( Nasdaq: DVAX) saw its shares plunge as much as 38% to $1.84 in pre-market trading…

Anti-viralsBiotechnologyDynavax TechnologiesHeplisavNorth AmericaRegulationVaccines

FDA approves Protein Sciences egg-free flu vaccine Flublok; and Octapharma's Octaplas


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

Anti-viralsBiotechnologyFlublokMergers & AcquisitionsNorth AmericaOctapharmaOctaplasPanblokPharmaceuticalProtein Sciences CorpRegulationVaccines

GlaxoSmithKline gains FDA approval of four-strain seasonal influenza vaccine


The US Food and Drug Administration has approved UK pharma giant GlaxoSmithKline's (LSE: GSK) Fluarix…

FluarixGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

Health Canada approves Vertex' Kalydeco; and Sanofi Pasteur's Menactra


Vertex Pharmaceuticals (Nasdaq: VRTX) says that Health Canada has approved Kalydeco (ivacaftor), the…

BiotechnologyKalydecoMenactraNorth AmericaPharmaceuticalRare diseasesRegulationSanofiSanofi PasteurVaccinesVertex

FDA approves Novartis' Flucelvax, first seasonal flu vaccine using cell culture technology


The US Food and Drug Administration yesterday approved Swiss drug major Novartis' (NOVN: VX) Flucelvax,…

FlucelvaxNorth AmericaNovartisPharmaceuticalProductionRegulationVaccines

FDA advisory panel backs GlaxoSmithKline H5N1 influenza vaccine candidate


The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC)…

GlaxoSmithKlineNorth AmericaPharmaceuticalPumarixRegulationVaccines

Novartis' flu vaccines suspended in several countries on suspected quality issues


A number of European Union member states have halted the use, as a precautionary measure, of some anti-influenza…

AgrifluAgrippalEuropeFluadMarkets & MarketingNorth AmericaNovartisPharmaceuticalRegulationVaccines

US FDA agrees to review Sanofi Pasteur's new quadrivalent influenza vaccine


Sanofi Pasteur, the vaccines division of Sanofi (Euronext: SAN) says it has filed a supplemental Biologics…

Anti-viralsNorth AmericaPharmaceuticalRegulationSanofiSanofi PasteurVaccines

Batch of mixed opinions from FDA advisory panels


Advisory panels of the US Food and Drug Administration meeting yesterday came back with a mixture of…

carfilzomibKyprolisMerck & CoNorth AmericaOncologyOnyx PharmaceuticalsPfizerPharmaceuticalPneumovaxPrevnarRegulationSanofisemuloparinVaccines

FDA approves GlaxoSmithKline's new combo vaccine MenHibrix


The US Food and Drug Administration has approved US pharma giant GlaxoSmithKline's (LSE: GSK) MenHibrix…

GlaxoSmithKlineMenHibrixNorth AmericaPharmaceuticalRegulationVaccines

FDA OKs first quadrivalent flu vaccine; and lower dose Angeliq


Anglo-Swedish drug major AstraZeneca (LSE: AZN) US unit MedImmune's FluMist Quadrivalent, a vaccine to…

Anti-viralsNorth AmericaPharmaceuticalRegulationVaccinesWomen's Health

FDA wants more info on Menveo; advisory negative on Dacogen


Swiss drug major Novartis (NOVN: VX) said this morning that it has received a Complete Response letter…

Astex PharmaceuticalsDacogenEisaiMenveoNorth AmericaNovartisOncologyPharmaceuticalRegulationVaccines




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