Regulation - North America, Novartis

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US FDA clears Xolair for chronic idiopathic urticaria

23-03-2014

Swiss drug major Novartis says the US Food and Drug Administration has approved Xolair (omalizumab) for…

BiotechnologyDermatologicalsGenentechNorth AmericaNovartisRegulationRocheUSAXolair

FDA investigating rare brain infection in patient taking Gilenya

30-08-2013

In a safety communication issued on Thursday (August 29), the US Food and Drug Administration is alerting…

GilenyaNeurologicalNorth AmericaNovartisPharmaceuticalRegulation

Novartis gains breakthrough therapy designation for sIBM drug from US FDA

20-08-2013

Swiss drug major Novartis (NOVN: VX) has gained US Food and Drug Administration breakthrough therapy…

bimagrumabInflammatory diseasesNorth AmericaNovartisPharmaceuticalRegulation

FDA expands age indication for Menveo, quadrivalent meningococcal vaccine

02-08-2013

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

MenveoNorth AmericaNovartisPharmaceuticalRegulationVaccines

"Breakthrough" status from FDA for Novartis' serelaxin (RLX030) for acute heart failure

21-06-2013

The US Food and Drug Administration has granted Breakthrough Therapy designation status to RLX030 (serelaxin),…

Cardio-vascularNorth AmericaNovartisPharmaceuticalRegulationRLX030serelaxin

US FDA approves Alcon's Simbrinza, a fixed-combination therapy for glaucoma

22-04-2013

Swiss drug major Novartis' (NOVN: VX) eye care division Alcon on Friday (April 19) received US Food and…

AlconNorth AmericaNovartisOphthalmicsPharmaceuticalRegulationSimbrinza

FDA approves Novartis' TOBI Podhaler and Cangene's first Botulism Antitoxin heptavalent

24-03-2013

The US Food and Drug Administration on Friday approved Swiss drug major Novartis' (NOVN: VX) TOBI Podhaler…

Antibiotics and Infectious diseasesBotulism antitoxinCangeneNorth AmericaNovartisPharmaceuticalRegulationRespiratory and PulmonaryTobi Podhaler

Novartis' LDK378 latest to receive FDA Breakthrough Therapy designation

15-03-2013

Swiss drug major Novartis (NOVN: VX) says that its investigational compound LDK378 has received Breakthrough…

LDK378North AmericaNovartisOncologyPharmaceuticalRegulation

Novartis' Zortress first drug in over a decade approved by FDA to prevent organ rejection

18-02-2013

Swiss drug major Novartis (NOVN: VX) said on Friday that the US Food and Drug Administration has approved…

ImmunologicalsNorth AmericaNovartisPharmaceuticalRegulationZortress

FDA clears new use for Roche's Avastin and Novartis' Exjade

25-01-2013

The US Food and Drug Administration has approved a new use for Swiss drug major Roche's (ROG: SIX) US…

AvastinBiotechnologyExjadeGenentechNorth AmericaNovartisOncologyPharmaceuticalRegulationRoche

US FDA approvals for Signifor, raxibacumab and Iclusig

17-12-2012

In a flurry of activity from the US Food and Drug Administration on Friday, the agency - which looks…

Antibiotics and Infectious diseasesAriad PharmaceuticalsGlaxoSmithKlineIclusigNorth AmericaNovartisOncologyPharmaceuticalRare diseasesraxibacumabRegulationSignifor

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

21-11-2012

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

FlucelvaxNorth AmericaNovartisPharmaceuticalProductionRegulationVaccines

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

29-10-2012

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

AgrifluAgrippalEuropeFluadMarkets & MarketingNorth AmericaNovartisPharmaceuticalRegulationVaccines

FDA approves Teva's Synribo for CML; Novartis plans for Tasigna switch

29-10-2012

The US Food and Drug Administration on Friday approved Israel-headquartered Teva Pharmaceutical Industries'…

GleevecNorth AmericaNovartisOncologyPatentsPharmaceuticalRegulationResearchSynriboTasignaTeva Pharmaceutical Industries

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

FDA backs higher dose of Novartis Exelon Patch for Alzheimer's

04-09-2012

The US Food and Drug Administration has approved a higher dose of Swiss drug major Novartis' (NOVN: VX)…

Exelon PatchNeurologicalNorth AmericaNovartisPharmaceuticalRegulation

FDA approves pediatric Afinitor from Novartis and Teva's tbo-filgrastim

30-08-2012

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

AfinitorBiotechnologyGenericsNorth AmericaNovartisOncologyPharmaceuticalRegulationSicor Biotechtbo-filgrastimTeva Pharmaceutical Industries

FDA advisory panel backs approval of ThromboGenics' ocriplasmin for VMA

29-07-2012

Belgian biopharmaceutical firm ThromboGenics NV (Euronext Brussels: THR) says that the US Food and Drug…

AlconBiotechnologyNorth AmericaNovartisocriplasminOphthalmicsRegulationThromboGenics

FDA backs Novartis' Afinitor for advanced breast cancer

23-07-2012

There was good news for Swiss drug major Novartis (NOVN: VX) on Friday, when the US Food and Drug Administration…

AfinitorNorth AmericaNovartisOncologyPharmaceuticalRegulation

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