Regulation - Novartis

Filter

Current filters:

Novartis

Popular Filters

1 to 25 of 159 results

Novartis receives fifth Breakthrough Therapy designation with CTL019 for leukemia

Novartis receives fifth Breakthrough Therapy designation with CTL019 for leukemia

08-07-2014

Swiss drug major Novartis has been granted Breakthrough Therapy designation for its leukemia treatment…

CancerCTL019LeukemiaNovartisOncologyPharmaceuticalRefractory acute lymphoblastic leukemiaRegulationUSA

UK’s NICE draft guidance backs Novartis’ Glivec for GISTs

UK’s NICE draft guidance backs Novartis’ Glivec for GISTs

27-06-2014

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

GlivecNovartisOncologyPharmaceuticalPricingRegulationUK

Novartis files for US approval of meningitis B vaccine Bexsero

Novartis files for US approval of meningitis B vaccine Bexsero

17-06-2014

Swiss pharma major Novartis has submitted a Biologic License Application to the US Food and Drug Administration…

BexseroBiotechnologyNovartisRegulationUSAVaccines

FDA licenses Novartis facility to produce cell-culture influenza vaccines

FDA licenses Novartis facility to produce cell-culture influenza vaccines

16-06-2014

The US Food and Drug Administration has licensed Swiss pharma major Novartis’ manufacturing facility…

FlucelvaxNovartisPharmaceuticalProductionRegulationUSAVaccines

Italian legislation undermines EU regulatory framework by endorsing off-label drug use for economic reasons

Italian legislation undermines EU regulatory framework by endorsing off-label drug use for economic reasons

11-06-2014

The European Federation of Pharmaceutical Industries and Associations says it is concerned about a decision…

AvastinEuropeFinancialItalyNovartisOphthalmicsPharmaceuticalRegulationRoche

Wider use of Novartis’ Gilenya approved in Europe

Wider use of Novartis’ Gilenya approved in Europe

09-06-2014

The European Commission has endorsed the recent Committee for Medicinal Products for Human Use (CHMP)…

EuropeGilenyaNeurologicalNovartisPharmaceuticalRegulation

EMA/CHMP again rejects Novartis’ serelaxin for AHF

26-05-2014

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

Cardio-vascularEuropeNovartisPharmaceuticalReasanzRegulationserelaxin

EMA/CHMP backs Alcon’s Simbrinza for glaucoma

25-05-2014

Swiss drug major Novartis’ eye care division Alcon says that the European Medicines Agency’s Committee…

AlconEuropeNovartisOphthalmicsPharmaceuticalRegulationSimbrinza

US FDA stalls approval of Novartis acute heart failure drug serelaxin, issuing a CRL

US FDA stalls approval of Novartis acute heart failure drug serelaxin, issuing a CRL

16-05-2014

The US Food and Drug Administration has issued a Complete Response Letter regarding the Biologics License…

Cardio-vascularNovartisPharmaceuticalReasanzRegulationserelaxinUSA

Novartis gains US approval for NSCLC drug candidate Zykadia

Novartis gains US approval for NSCLC drug candidate Zykadia

30-04-2014

The US Food and Drug Administration said late yesterday that it has granted accelerated approval for…

NovartisOncologyPharmaceuticalRegulationUSAZykadia

First Asian approval for ophthalmic drug Jetrea, in Malaysia

18-04-2014

Belgian biotech firm ThromboGenics NV revealed today that Jetrea (ocriplasmin) has been approved in Malaysia…

AlconAsia-PacificBiotechnologyJetreaMalaysiaNovartisOphthalmicsRegulationThromboGenics

US FDA advisory panel votes against approval of Novartis’ AHF drug

US FDA advisory panel votes against approval of Novartis’ AHF drug

28-03-2014

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee yesterday voted…

Cardio-vascularNorth AmericaNovartisPharmaceuticalReasanzRegulationserelaxinUSA

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

UK about turn, as JCVI now recommends meningitis B vaccination for infants

21-03-2014

The UK’s Joint Committee on Vaccination and Immunization has recommended that the meningitis B vaccine…

BexseroNorthern EuropeNovartisPharmaceuticalRegulationUKVaccines

Ph III study for Jakavi meets endpoint in patients with polycythemia vera

Ph III study for Jakavi meets endpoint in patients with polycythemia vera

07-03-2014

Swiss pharma major Novartis today announced positive results from a pivotal Phase III trial of Jakavi…

IncyteJakaviNovartisOncologyPharmaceuticalRare diseasesRegulationResearch

Novartis gets fourth indication, DME, for Lucentis in Japan

24-02-2014

Swiss drug major Novartis says it has received approval from Japanese regulatory bodies for a fourth…

Asia-PacificJapanLucentisNovartisOphthalmicsPharmaceuticalRegulation

EMA/CHMP gives Novartis positive opinion for Xolair; negative opinion on RLX030 to be appealed

EMA/CHMP gives Novartis positive opinion for Xolair; negative opinion on RLX030 to be appealed

24-01-2014

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given…

Cardio-vascularEuropeNovartisPharmaceuticalRegulationRespiratory and PulmonaryXolair

NICE final guidance gives green light to Lucentis for CNV

NICE final guidance gives green light to Lucentis for CNV

27-11-2013

The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance recommending…

EuropeLucentisNovartisOphthalmicsPharmaceuticalPricingRegulation

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

NICE gives green light to Novartis’ Lucentis for eye condition

NICE gives green light to Novartis’ Lucentis for eye condition

25-10-2013

NICE has issued final draft guidance recommending Novartis' Lucentis for people with pathological myopia.

EuropeLucentisNovartisOphthalmicsPharmaceuticalRegulation

1 to 25 of 159 results

Back to top