Regulation - North America, Pfizer

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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

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

16-03-2014

The US Food and Drug Administration has approved pharma major Bristol-Myers Squibb’s supplemental New…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulationUSA

Pfizer’s Xalkori gains regular FDA approval for NSCLC

Pfizer’s Xalkori gains regular FDA approval for NSCLC

22-11-2013

The US Food and Drug Administration yesterday (November 21) granted pharma behemoth Pfizer’s Xalkori…

North AmericaOncologyPfizerPharmaceuticalRegulationXalkori

ViiV Healthcare’s Tivicay approved in Canada for HIV

04-11-2013

ViiV Healthcare, the HIV/AIDS joint venture set up by UK pharma giant GlaxoSmithKline with US behemoth…

Anti-viralsdolutegravirGlaxoSmithKlineNorth AmericaPfizerPharmaceuticalRegulationShionogiTivicayViiV Healthcare

US FDA backs Pfizer’s hot flashes drug Duavee

US FDA backs Pfizer’s hot flashes drug Duavee

04-10-2013

Pfizer and partner Ligand Pharmaceuticals say that the US Food and Drug Administration has approved Duavee,…

bazedoxifeneDuaveeLigand PharmaceuticalsNorth AmericaPfizerPharmaceuticalRegulationWomen's Health

FDA issues new Boxed Warning on Pfizer antibacterial

FDA issues new Boxed Warning on Pfizer antibacterial

28-09-2013

The US Food and Drug Administration is warning that an additional analysis shows an increased risk of…

Antibiotics and Infectious diseasesNorth AmericaPfizerPharmaceuticalRegulationTygacil

FDA approves new ViiV Healthcare HIV drug

13-08-2013

The US Food and Drug Administration yesterday (August 12) approved Tivicay (dolutegravir), a new drug…

Anti-viralsdolutegravirGlaxoSmithKlineNorth AmericaPfizerPharmaceuticalRegulationShionogiTivicayViiV Healthcare

US FDA accepts Bristol-Myers/Pfizer' Eliquis sNDA

12-07-2013

US pharma major Bristol-Myers Squibb (NYSE: BMY) and behemoth Pfizer (NYSE: PFE) announced that the US…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulation

Breakthrough status for Pfizer's palbociclib; Merck & Co Noxafil NDA accepted

11-04-2013

Global pharma behemoth Pfizer (NYSE: PFE) is the latest to gain a "Breakthrough Therapy" designation…

Antibiotics and Infectious diseasesMerck & CoNorth AmericaNoxafilOncologypalbociclibPfizerPharmaceuticalRegulation

Merck & Co gets all clear to continue Vytorin study; FDA warns on Pfizer's Zithromax

13-03-2013

US pharma giant Merck & Co said yesterday that the Data Safety Monitoring Board (DSMB) of the IMPROVE-IT…

Antibiotics and Infectious diseasesCardio-vascularMerck & CoNorth AmericaPfizerPharmaceuticalRegulationResearchVytorinZithromax

$30 billion of fresh opportunities for Rx-to-OTC switch in USA

19-02-2013

The US Food and Drug Administration has recently created the Non-prescription Safe Use Regulatory Expansion…

LipitorMarkets & MarketingNorth AmericaPfizerPharmaceuticalRegulation

Pfizer's Quillivant XR oral suspension now available in USA; GlaxoSmithKline files BLA for albiglutide

15-01-2013

Confirming expectations announced when Pfizer (NYSE: PFE) revealed its $680 million acquisition of NextWave…

albiglutideDiabetesGlaxoSmithKlineMarkets & MarketingNeurologicalNorth AmericaPfizerPharmaceuticalQuillivantRegulation

US FDA approves Merck KGaA's Rebif Rebidose

04-01-2013

German drug major Merck KGaA's (MRK: DE) US subsidiary EMD Serono and pharma behemoth Pfizer (NYSE: PFE)…

BiotechnologyEMD SeronoMerck KGaANeurologicalNorth AmericaPfizerPharmaceuticalRebifRegulation

US FDA finally approves Bristol-Myers/Pfizer's Eliquis for stroke prevention in AF patients

31-12-2012

The US Food and Drug Administration on December 28 finally approved the anti-clotting drug Eliquis (apixaban),…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulation

Watson gains FDA approval for generic Revatio

12-11-2012

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) has received approval from the US Food and Drug…

GenericsNorth AmericaPfizerRegulationRespiratory and PulmonaryRevatioWatson Pharmaceuticals

FDA approves Pfizer's Xeljanz for rheumatoid arthritis

07-11-2012

Having in the summer put back its "action date" due to a request for additional analysis of the existing…

Anti-Arthritics/RheumaticsNorth AmericaPfizerPharmaceuticalRegulationtofacitinibXeljanz

FDA sets March 2013 PDUFA date for re-submitted Eliquis

28-09-2012

The US Food and Drug Administration has acknowledged receipt of the New Drug Application resubmission…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulation

Mylan debuts first generic Diovan HCT and Antivert copy in USA

23-09-2012

US generic drugmaker Mylan (Nasdaq: MYL) last Friday received final approval from the US Food and Drug…

AntivertCardio-vascularDiovan HCTGenericsMarkets & MarketingMylan LaboratoriesNeurologicalNorth AmericaNovartisPfizerRegulation

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