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US FDA issues warning on Pfizer’s Geodon

US FDA issues warning on Pfizer’s Geodon

11-12-2014

The US Food and Drug Administration is warning that the antipsychotic drug ziprasidone (marketed under…

GeodonNeurologicalPfizerPharmaceuticalRegulationUSAZiprasidone

Mixed findings from IQWiG on added benefit for Eliquis

05-12-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined a dossier on Eliquis…

Bristol-Myers SquibbCardio-vascularEliquisGermanyPfizerPharmaceuticalPricingRegulation

UK's NICE does not recommend Pfizer's Xiapex for Dupuytren's contracture

UK's NICE does not recommend Pfizer's Xiapex for Dupuytren's contracture

07-11-2014

The UK’s National Institute for Health and Care Excellence is consulting on provisional recommendations…

Anti-Arthritics/RheumaticsPfizerPharmaceuticalRegulationUKXiapex

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

US FDA backs abuse deterrent labeling for Pfizer’s Embeda ER

19-10-2014

The US Food and Drug Administration has approved an updated label for pharma giant Pfizer’s Embeda…

AvinzaEmbedaNeurologicalPfizerPharmaceuticalRegulationUSA

US FDA panel votes to keep Chantix black box warning; staffers recommend secukinumab

US FDA panel votes to keep Chantix black box warning; staffers recommend secukinumab

17-10-2014

The US Food and Drug Administration's advisory panel has voted to keep a black box warning on US pharma…

ChantixNovartisPfizerPharmaceuticalRegulationsecukinumabUSA

Actavis challenges Quillivant XR patent

16-10-2014

Ireland-headquartered generics major Actavis confirmed that it has filed an Abbreviated New Drug Application…

ActavisGenericsLegalNeurologicalPatentsPfizerQuillivantRegulationTris PharmaUSA

Pfizer’s palbociclib gains FDA Priority Review

13-10-2014

Pfizer says that the New Drug Application for its investigational breast cancer treatment palbociclib…

OncologypalbociclibPfizerPharmaceuticalRegulationUSA

FDA approves Elelyso for pediatric use in Gaucher disease

FDA approves Elelyso for pediatric use in Gaucher disease

29-08-2014

The US Food and Drug Administration has approved US pharma giant Pfizer’s Elelyso (taliglucerase alfa)…

ElelysoPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesRegulationUSA

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

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