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ViiV Healthcare gains FDA approval for HIV drug Triumeq

ViiV Healthcare gains FDA approval for HIV drug Triumeq

23-08-2014

The US Food and Drug Administration has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine…

Anti-viralsGlaxoSmithKlinePfizerPharmaceuticalRegulationShionogiTriumeqUSAViiV Healthcare

FDA expands indication for Eliquis to treatment of DVT and PE

FDA expands indication for Eliquis to treatment of DVT and PE

22-08-2014

US pharma majors Bristol-Myers Squibb and Pfizer late yesterday said that the US Food and Drug Administration…

Boehringer IngelheimCardio-vascularEliquisPfizerPharmaceuticalPulmonary embolismRegulationUSA

Pfizer files palbociclib NDA with FDA for breast cancer

Pfizer files palbociclib NDA with FDA for breast cancer

19-08-2014

US pharma giant Pfizer says it has completed the submission of a New Drug Application to the US Food…

OncologypalbociclibPfizerPharmaceuticalRegulationUSA

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

New indications approved in EU for Bristol-Myers/Pfizer Eliquis

New indications approved in EU for Bristol-Myers/Pfizer Eliquis

30-07-2014

The European Commission has approved US pharma majors Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban)…

Bristol-Myers SquibbCardio-vascularEliquisEuropePfizerPharmaceuticalRegulation

South Africa regulator gives MSF access to cheaper TB drug linezolid

South Africa regulator gives MSF access to cheaper TB drug linezolid

01-07-2014

After a three-year long struggle, humanitarian aid agency Medecins Sans Frontieres has received approval…

Antibiotics and Infectious diseasesGenericsHealthcareLinezolidPfizerRegulationSouth AfricaZyvox

Pfizer to submit NDA for breast cancer drug palbociclib later this year

18-05-2014

US pharma giant Pfizer says that it will submit a New Drug Application with the US Food and Drug Administration…

OncologypalbociclibPfizerPharmaceuticalRegulationUSA

EMA advisory committee backs addition for Eliquis SmPC

EMA advisory committee backs addition for Eliquis SmPC

02-05-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended…

Bristol-Myers SquibbCardio-vascularEliquisPfizerPharmaceuticalRegulation

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

Negative NICE appraisal of Pfizer’s Bosulif for CML

Negative NICE appraisal of Pfizer’s Bosulif for CML

27-11-2013

UK drug watchdog the National Institute for Health and Care Excellence (NICE) has issued final guidance…

BosulifEuropeOncologyPfizerPharmaceuticalPricingRare diseasesRegulation

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

Regulator backs Inlyta, Lucentis and Xtandi for NHS Scotland, but not Bosulif

12-11-2013

The Scottish Medicines Consortium (SMC) revealed this morning (November 12) that it has accepted US drug…

Astellas PharmaBosulifEuropeInlytaLucentisNovartisOncologyOphthalmicsPfizerPharmaceuticalRegulationXtandi

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

Report: Tarceva and Iressa favored by European oncologists for NSCLC

Report: Tarceva and Iressa favored by European oncologists for NSCLC

04-11-2013

Oncologists across the top five European countries are prescribing Roche's Tarceva or AstraZeneca's Iressa…

AstraZenecaEuropeIressaOncologyPfizerPharmaceuticalPricingRegulationRocheTarcevaXalkori

Updated EU labeling for Pfizer’s Prevenar 13

Updated EU labeling for Pfizer’s Prevenar 13

17-10-2013

The European Commission has approved updates to the Summary of Product Characteristics for US pharma…

EuropePfizerPharmaceuticalPrevenarRegulationVaccines

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

NICE says Xalkori is not cost effective in ALK-positive NSCLC

20-08-2013

US pharma behemoth Pfizer (NYSE: PFE) has today (August 16) expressed concern and disappointment that…

EuropeOncologyPfizerPharmaceuticalPricingRegulationXalkori

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