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IQWiG now finds added benefit for Provenge

23-03-2015

Reversing a previous negative opinion, the German Institute for Quality and Efficiency in Health Care…

BiotechnologyDendreonGermanyOncologyPricingProvengeRegulationValeant Pharmaceutical International

EC approves new indication for Novartis’ Jakavi

EC approves new indication for Novartis’ Jakavi

17-03-2015

The European Commission has approved Swiss pharma giant Novartis’ Jakavi (ruxolitinib) for the treatment…

BiotechnologyEuropeIncyte CorpJakafiJakaviNovartisOncologyRegulation

NICE recommends GSK’s Arzerra for chronic lymphocytic leukemia

NICE recommends GSK’s Arzerra for chronic lymphocytic leukemia

11-03-2015

Confirming an earlier preliminary guidance, medicines cost watchdog for England, the National Institute…

ArzerraGlaxoSmithKlineOncologyPharmaceuticalPricingRegulationUK

Merck’s pembrolizumab is first drug to be made available through UK’s EAMS for advanced melanoma

Merck’s pembrolizumab is first drug to be made available through UK’s EAMS for advanced melanoma

11-03-2015

US pharma giant Merck & Co revealed yesterday that its anti-PD-1 therapy, pembrolizumab, which is marketed…

KeytrudaMarkets & MarketingMerck & CoOncologypembrolizumabPharmaceuticalRegulationUK

Eisai's Halaven to stay on UK Cancer Drugs Fund list pending reconsideration

Eisai's Halaven to stay on UK Cancer Drugs Fund list pending reconsideration

11-03-2015

Japanese drug major Eisai has announced that its drug Halaven (eribulin) will remain on the UK's National…

EisaiHalavenOncologyPharmaceuticalRegulationUK

NICE says ‘yes’ to new blood cancer drug from Roche

NICE says ‘yes’ to new blood cancer drug from Roche

11-03-2015

Patients in England and Wales with chronic lymphocytic leukemia (CLL) could soon benefit from Gazyvaro…

BiotechnologyGazyvaroOncologyPricingRegulationRocheUK

FDA approves Unituxin for high-risk neuroblastoma

FDA approves Unituxin for high-risk neuroblastoma

10-03-2015

The US Food and Drug Administration today approved US biotech firm United Therapeutics’ Unituxin (dinutuximab)…

BiotechnologyOncologyRegulationUnited TherapeuticsUnituxinUSA

Scottish Medicines Consortium approves Gilead's Zydelig and B-MS/Pfizer's Eliquis

Scottish Medicines Consortium approves Gilead's Zydelig and B-MS/Pfizer's Eliquis

09-03-2015

The Scottish Medicines Consortium has approved Zydelig (idelalisib) from Gilead for adult chronic lymphocytic…

EliquisGileadHematologyOncologyPharmaceuticalRegulationUKZydelig

Prime Therapeutics welcomes FDA's approval of first biosimilar in USA, but says more clarity is needed

Prime Therapeutics welcomes FDA's approval of first biosimilar in USA, but says more clarity is needed

09-03-2015

Prime Therapeutics, a non-profit US pharmacy benefit manager serving more than 26 million members, has…

AmgenBiosimilarsBiotechnologyNeupogenNovartisOncologyRegulationSandozUSAZarxio

Sandoz’s Zarxio first biosimilar to be approved under new FDA pathway

Sandoz’s Zarxio first biosimilar to be approved under new FDA pathway

06-03-2015

Sandoz, the generics unit of Swiss pharma giant Novartis, today received approval from the US Food and…

AmgenBiosimilarsBiotechnologyNeupogenNovartisOncologyRegulationSandozUSAZarxioZarzio

US FDA expands use of Bristol-Myers’ Opdivo to NSCLC

US FDA expands use of Bristol-Myers’ Opdivo to NSCLC

05-03-2015

The US Food and Drug Administration late yesterday expanded the approved use of pharma major Bristol-Myers…

BiotechnologyBristol-Myers SquibbOncologyOpdivoRegulationUSA

Oncolytics Biotech gains third orphan status for Reolysin

Oncolytics Biotech gains third orphan status for Reolysin

03-03-2015

Canada’s Oncolytics Biotech revealed today that the US Food and Drug Administration has granted Orphan…

BiotechnologyOncologyOncolytics BiotechRare diseasesRegulationReolysinUSA

Celgene’s Abraxane gains new indication in Europe

02-03-2015

The European Commission has approved US biotech firm Celgene’s Abraxane (paclitaxel formulated as albumin-bound…

AbraxaneBiotechnologyCelgene CorpEuropeOncologyRegulation

Taiho Pharma Europe submits marketing application to EMA for TAS-102 in colorectal cancer

Taiho Pharma Europe submits marketing application to EMA for TAS-102 in colorectal cancer

02-03-2015

Taiho Pharma Europe, a subsidiary of Japanese pharma company Otsuka (TYO: 4768), has submitted a marketing…

EuropeOncologyPharmaceuticalRegulationTaiho PharmaceuticalsTAS-102

EMA/CHMP backs Roche’s Avastin plus chemotherapy in advanced cervical cancer

EMA/CHMP backs Roche’s Avastin plus chemotherapy in advanced cervical cancer

28-02-2015

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

AvastinBiotechnologyEuropeOncologyRegulationRoche

Three new drugs recommended for approval by EMA/CHMP

Three new drugs recommended for approval by EMA/CHMP

27-02-2015

Three new medicines have been recommended for approval at the February 2015 meeting of the European Medicines…

AmgenEuropeJinarcNephrology and HepatologyNovartisOncologyOtsuka PharmaceuticalPharmaceuticalRegulationRistempaVectibixZykadia

Amgen and Onyx’s MAA for Kyprolis is accepted by EMA

Amgen and Onyx’s MAA for Kyprolis is accepted by EMA

27-02-2015

The European Medicines Agency has accepted the Marketing Authorization Application for Kyprolis (carfilzomib)…

AmgenEuropeKyprolisOncologyOnyx PharmaceuticalsPharmaceuticalRegulation

NICE recommends Pfizer's Inlyta but not Dendreon's Provenge

NICE recommends Pfizer's Inlyta but not Dendreon's Provenge

25-02-2015

The UK’s National Institute for Health and Care Excellence has recommended Inlyta (axitinib), marketed…

DendreonInlytaOncologyPfizerPharmaceuticalPricingProvengeRegulationUKValeant Pharmaceuticals International

Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

24-02-2015

The US Federal Trade Commission has put conditions on the proposed acquisition by Novartis of GlaxoSmithKline’s…

Array BioPharmaGSKLegalMergers & AcquisitionsNovartisOncologyPharmaceuticalRegulationResearchUSA

US FDA approves Novartis’ Farydak, the first HDAC inhibitor for MM patients

24-02-2015

The US Food and Drug Administration yesterday approved Swiss pharma giant Novartis’ Farydak (panobinostat,…

FarydakNovartisOncologypanobinostatPharmaceuticalRegulationUSA

European approval for expanded use of Celgene’s Revlimid

20-02-2015

US biotech firm Celgene’s European subsidiary has received approval from the European Commission for…

BiotechnologyCelgene CorpEuropeOncologyRegulationRevlimid

FDA accepts and grants priority review for Genentech's cobimetinib/Zelboraf

FDA accepts and grants priority review for Genentech's cobimetinib/Zelboraf

20-02-2015

Genentech, part of the Roche Group, says that the US Food and Drug Administration has accepted and granted…

cobimetinibGenentechOncologyPharmaceuticalRegulationRocheUSA

US FDA expands use of Celgene’s Revlimid

18-02-2015

US biotech firm Celgene revealed that the US Food and Drug Administration has expanded the existing indication…

BiotechnologyCelgene CorpOncologyRegulationRevlimidUSA

US Orphan Drug status for Bexion’s Saposin C for glioblastoma

US Orphan Drug status for Bexion’s Saposin C for glioblastoma

17-02-2015

Privately-held US biotech firm Bexion Pharmaceuticals has received Orphan Drug designation for the US…

Bexion PharmaceuticalsBiotechnologyBXQ-350OncologyRegulationSaposin CUSA

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