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Orphan status for Navidea’s Lymphoseek in head and neck cancers

Orphan status for Navidea’s Lymphoseek in head and neck cancers

19-09-2014

US biotech company Navidea Biopharmaceuticals that its Lymphoseek (technetium Tc 99m tilmanocept) Injection…

BiotechnologyLymphoseekNavidea BiopharmaceuticalsOncologyRegulationUSA

UK’s NICE proposes to recommend GSK’s Tafinlar for melanoma

UK’s NICE proposes to recommend GSK’s Tafinlar for melanoma

18-09-2014

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

GlaxoSmithKlineOncologyPharmaceuticalPricingRegulationRocheTafinlarUKZelboraf

First therapy under UK’s early access scheme to be Northwest Biotherapeutics’ DCVax-L

First therapy under UK’s early access scheme to be Northwest Biotherapeutics’ DCVax-L

17-09-2014

The UK’s Department of Health announced that DCVax-L, the dendritic cell-based vaccine from US company…

BiotechnologyDCVaxNorthwest BiotherapeuticsOncologyRegulationUK

Cost of Abraxane not justified, says NICE in draft guidance for use in pancreatic cancer

Cost of Abraxane not justified, says NICE in draft guidance for use in pancreatic cancer

09-09-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has published new draft…

AbraxaneBiotechnologyCelgene Corp.OncologyPaclitaxelPricingRegulationUK

Astellas' isavuconazole NDA accepted by US FDA

Astellas' isavuconazole NDA accepted by US FDA

08-09-2014

The US Food and Drug Administration has accepted a New Drug Application filing by Japanese drug major…

Astellas PharmaFungal diseasesInvasive aspergillosisInvasive mucormycosisisavuconazoleOncologyPharmaceuticalRegulationUSA

FDA lifts partial clinical hold on OncoMed's ipafricept

05-09-2014

Shares of US biotech companies OncoMed Pharmaceuticals rose 5.6% to $17.68 on news that the US Food and…

BayerBiotechnologyipafriceptOncologyOncoMed PharmaceuticalsRegulationResearchUSA

Merck & Co’s melanoma drug Keytruda becomes first FDA-approved anti-PD-1 therapy

Merck & Co’s melanoma drug Keytruda becomes first FDA-approved anti-PD-1 therapy

05-09-2014

The US Food and Drug Administration has granted accelerated approval for pharma giant Merck & Co’s…

KeytrudaMerck & CoOncologypembrolizumabPharmaceuticalRegulationUSA

Ipsen receives priority review for sNDA for Somatuline

Ipsen receives priority review for sNDA for Somatuline

01-09-2014

French drugmaker Ipsen has received priority review for its supplemental New Drug Application from the…

Gastroenteropancreatic neuroendocrine tumorsIpsenOncologyPharmaceuticalRegulationSomatulineUS Food and Drug AdministrationUSA

Green Cross Neulapeg biosimilar approved in South Korea

28-08-2014

South Korea’s Green Cross says that the country’s Ministry of Food and Drug Safety has granted marketing…

AmgenAsia-PacificBiosimilarsBiotechnologyGreen CrossNeulapegNeulastaOncologyRegulation

NHS England boosts the Cancer Drugs Fund for more access to innovative medicines

NHS England boosts the Cancer Drugs Fund for more access to innovative medicines

28-08-2014

The National Health Service England has pledged to boost the Cancer Drugs Fund by £160 million ($265…

Cancer Drugs FundNHS EnglandOncologyPharmaceuticalRegulationUK

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

NICE U-turn on Celgene’s Revlimid for myelodysplastic syndromes

NICE U-turn on Celgene’s Revlimid for myelodysplastic syndromes

20-08-2014

UK drugs watch dog the National Institute for Health and Care Excellence (NICE) has issued final draft…

BiotechnologyCelgene Corp.Myelodysplastic syndromesOncologyPricingRegulationRevlimidUK

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

Eisai files for US and EU approval of lenvatinib for hard to treat thyroid cancer

Eisai files for US and EU approval of lenvatinib for hard to treat thyroid cancer

18-08-2014

Japanese pharma major Eisai has filed applications with the US Food and Drug Administration and the European…

DonepezilEisaiEuropelenvatinibOncologyPharmaceuticalRegulationUSA

Amgen issues voluntary recall of Aranesp prefilled syringes in certain countries

Amgen issues voluntary recall of Aranesp prefilled syringes in certain countries

15-08-2014

USA-based Amgen initiated a voluntary recall on June 26 for nine packaged lots of anemia drug Aranesp…

AmgenAnemiaAranespBiotechnologyMarkets & MarketingOncologyRegulation

Roche’s Avastin gets FDA approval for use with chemotherapy in cervical cancer

Roche’s Avastin gets FDA approval for use with chemotherapy in cervical cancer

15-08-2014

Swiss drug major Roche has received approval from the US Food and Drug Administration for its drug Avastin…

AvastinCervical cancerOncologyPharmaceuticalRegulationRocheSwitzerland

NICE says benefit of prostate cancer drug Zytiga does not justify price

NICE says benefit of prostate cancer drug Zytiga does not justify price

15-08-2014

The UK’s National Institute for Health and Care Excellence (NICE) has not recommended Zytiga (abiraterone)…

AbirateroneAndrew DillonJanssenOncologyPharmaceuticalRegulationUKZytiga

Kadcyla’s rejection confirms that NICE must change the way it considers cancer treatment, says analyst

Kadcyla’s rejection confirms that NICE must change the way it considers cancer treatment, says analyst

13-08-2014

“The National Institute for Health and Care Excellence’s recent rejection of Kadcyla, Roche’s latest…

KadcylaOncologyPharmaceuticalPricingRegulationRocheUK

FDA fast tracks CTI BioPharma's pacritinib for myelofibrosis

FDA fast tracks CTI BioPharma's pacritinib for myelofibrosis

08-08-2014

US biotech firm CTI BioPharma (formerly called Cell Therapeutics) says that its pacritinib has been granted…

CTI BioPharmaOncologypacritinibPharmaceuticalRegulationUSA

NICE disappointed by Roche’s decision on Kadcyla pricing

NICE disappointed by Roche’s decision on Kadcyla pricing

08-08-2014

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) said this morning…

Breast cancerCancerKadcylaNational Health ServiceOncologyPharmaceuticalPricingRegulationRocheUK

NICE comes back with different views on Tarceva and Iressa for NSCLC

NICE comes back with different views on Tarceva and Iressa for NSCLC

07-08-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) is consulting again…

AstraZenecaIressaOncologyPharmaceuticalPricingRegulationRocheTarcevaUK

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