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Novartis gains US FDA approval of Signifor for acromegaly

Novartis gains US FDA approval of Signifor for acromegaly

16-12-2014

The US Food and Drug Administration has approved Swiss pharma giant Novartis’ Signifor (pasireotide)…

NovartisPharmaceuticalRare diseasesRegulationSigniforUSA

Added benefit of Eylea over Lucentis in DME not proven, says IQWiG

Added benefit of Eylea over Lucentis in DME not proven, says IQWiG

16-12-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has compared trial data on German…

BayerEyleaGermanyLucentisNovartisOphthalmicsPharmaceuticalPricingRegulationRoche

EMA committee concludes no evidence Fluad caused deaths

EMA committee concludes no evidence Fluad caused deaths

04-12-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that…

EuropeFluadNovartisPharmaceuticalRegulationVaccines

Two batches of Novartis' Fluad taken off market for investigation in Italy after 13 deaths

Two batches of Novartis' Fluad taken off market for investigation in Italy after 13 deaths

01-12-2014

The Italian Medicines Agency (AIFA) has suspended two batches of Swiss drug major Novartis’ Fluad seasonal…

Anti-viralsFluadItalian Medicines AgencyItalyNovartisPharmaceuticalRegulation

Novartis’ heart failure drug LCZ696 granted accelerated assessment by CHMP

Novartis’ heart failure drug LCZ696 granted accelerated assessment by CHMP

28-11-2014

Swiss drug major Novartis announced that the European Medicines Agency’s Committee for Medicinal Products…

Cardio-vascularEuropeLCZ696NovartisPharmaceuticalRegulation

FTC puts conditions on GSK/Novartis consumer JV

27-11-2014

The US Federal Trade Commission has voted to approve UK pharma giant GlaxoSmithKline’s proposed acquisition…

Dr Reddy's LaboratoriesGlaxoSmithKlineHabitrolMergers & AcquisitionsNicodermNovartisPharmaceuticalRegulationUSAVaccines

NICE updated guidance backs Novartis’ Glivec for GIST

26-11-2014

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

GlivecNovartisOncologyPharmaceuticalPricingRegulationUK

Novartis' Signifor approved in EU for acromegaly patients

Novartis' Signifor approved in EU for acromegaly patients

25-11-2014

The European Commission has approved Swiss drug major Novartis’ Signifor (pasireotide) for patients…

NovartisPharmaceuticalRare diseasesRegulationSigniforSwitzerland

US FDA pushes back decision date for Novartis’ panobinostat

US FDA pushes back decision date for Novartis’ panobinostat

25-11-2014

The US Food and Drug Administration has extended its priority review period by up to three months for…

FarydakNovartisOncologypanobinostatPharmaceuticalRegulationUSA

Future bleak for Novartis’ panobinostat in relapsed/refractory multiple myeloma, says analyst

21-11-2014

The vote against the recommendation that the US Food and Drug Administration approves Novartis’ panobinostat…

daratumumabelotuzumabFarydakNovartisOncologypanobinostatPharmaceuticalRegulation

Novartis’ Cosentyx wins positive opinion from EMA’s CHMP

Novartis’ Cosentyx wins positive opinion from EMA’s CHMP

21-11-2014

Swiss pharma giant Novartis this morning revealed that the European Medicines Agency’s Committee for…

BiotechnologyCosentyxDermatologicalsEuropeNovartisRegulationsecukinumab

NICE seeks more information on Xolair to treat hives

19-11-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Swiss…

DermatologicalsNovartisPharmaceuticalPricingRegulationUKXolair

Scottish backing for Novartis’ Afinitor for kidney cancer patients

Scottish backing for Novartis’ Afinitor for kidney cancer patients

10-11-2014

The Scottish Medicines Consortium has issued a positive recommendation for Swiss pharma major Novartis’…

AfinitorClinical pharmacologyHealthHealth Medical PharmaNHSNovartisOncologyPharmaceuticalPricingRegulationUK

FDA advisory panel votes against approval of Novartis MM drug

07-11-2014

At a meeting yesterday, the US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC)…

LBH589NovartisOncologypanobinostatPharmaceuticalRegulationUSA

FDA panel unanimously backs Novartis’ secukinumab for moderate-to-severe plaque psoriasis

FDA panel unanimously backs Novartis’ secukinumab for moderate-to-severe plaque psoriasis

21-10-2014

The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration…

DermatologicalsNovartisPharmaceuticalRegulationsecukinumabUSA

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

NICE reverses guidance on Novartis’ Glivec for GIST

NICE reverses guidance on Novartis’ Glivec for GIST

17-10-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued new…

GlivecNovartisOncologyPharmaceuticalPricingRegulationUK

IQWiG finds added benefit of Novartis’ Gilenya not proven

IQWiG finds added benefit of Novartis’ Gilenya not proven

10-10-2014

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

GermanyGilenyaNeurologicalNovartisPharmaceuticalPricingRegulation

Novartis' investigational heart failure drug LCZ696 shows striking efficacy

Novartis' investigational heart failure drug LCZ696 shows striking efficacy

31-08-2014

Swiss drug major Novartis on Saturday presented striking new data for its LZC696 heart drug at the European…

Cardio-vascularLCZ696NovartisPharmaceuticalRegulationResearch

IQWiG finds added benefit for Novartis’ Jakavi in myelofibrosis

IQWiG finds added benefit for Novartis’ Jakavi in myelofibrosis

20-08-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products,…

Federal Joint CommitteeGermanyJakaviMyelofibrosisNovartisOncologyPharmaceuticalPricingRare diseasesRegulation

Sandoz application for biosimilar Neupogen accepted by US FDA

25-07-2014

The US Food and Drug Administration has accepted the Biologics License Application for filgrastim, which…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarzio

$25 million milestone for Incyte on Japanese approval of Jakavi

$25 million milestone for Incyte on Japanese approval of Jakavi

08-07-2014

US biopharma company Incyte says it has earned a $25 million milestone payment from Swiss drug major…

BiotechnologyBusiness FinanceBusiness FinanceFinancialIncyteJakaviJapanMajorMedicineNovartisOncologyRegulationRuxolitinib

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