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German Federal Joint Committee confirms 'considerable' benefit of Eisai's Halaven in breast cancer

German Federal Joint Committee confirms 'considerable' benefit of Eisai's Halaven in breast cancer

23-01-2015

The German Federal Joint Committee has confirmed the ‘considerable’ additional benefit of Japanese…

EisaiGermanyHalavenOncologyPharmaceuticalRegulation

IQWiG reports negative views on Provenge, Velphoro and Zydelig

IQWiG reports negative views on Provenge, Velphoro and Zydelig

22-01-2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has reviewed a number of dossiers…

DendreonGermanyGilead SciencesNephrology and HepatologyOncologyPharmaceuticalPricingProvengeRegulationVelphoroVifor PharmaZydelig

Ariad gets positive final EC decision on Iclusig

20-01-2015

USA-based Ariad Pharmaceuticals today revealed that the European Commission has endorsed the final opinion…

Ariad PharmaceuticalsEuropeIclusigOncologyPharmaceuticalRegulation

FDA removes hold on CytRx's aldoxorubicin Phase III trials

FDA removes hold on CytRx's aldoxorubicin Phase III trials

20-01-2015

The US Food and Drug Administration has removed the partial clinical hold on biopharma oncology company…

aldoxorubicinBiotechnologyCytRxOncologyRegulationResearchUSA

Merck & Co updates on plans to accelerate new drug submissions and future growth

Merck & Co updates on plans to accelerate new drug submissions and future growth

13-01-2015

US pharma giant Merck & Co has reported on the ongoing execution of its multi-year, strategic initiative…

Anti-viralsgrazoprevir/elbasvirKeytrudaMerck & CoOncologyPharmaceuticalRegulationResearchUSA

Cost to NHS of Provenge too high to be recommended, says NICE

13-01-2015

England’s health care cost watchdog the National Institute for Health and Care Excellence (NICE) has…

BiotechnologyDendreonOncologyPricingProvengeRegulationUK

China’s FDA approves Chipscreen’s Epidaza

China’s FDA approves Chipscreen’s Epidaza

12-01-2015

Chinese biotech firm Chipscreen Biosciences has received regulatory approval of Epidaza (chidamide),…

BiotechnologychidamideChinaChipscreen BiosciencesEpidazaOncologyRegulation

FDA sees no need for advisory panel meeting over Pfizer’s Ibrance

09-01-2015

US pharma giant Pfizer says it has been advised by the Food and Drug Administration that at this time…

IbranceOncologypalbociclibPfizerPharmaceuticalRegulationUSA

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

08-01-2015

The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC), in a unanimous vote, recommended…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarxio

FDA grants Soligenix Fast Track status for SGX301

FDA grants Soligenix Fast Track status for SGX301

07-01-2015

Late-stage biopharma company Soligenix has said that its SGX301 (synthetic hypericin) development program…

OncologyPharmaceuticalRegulationSGX301SoligenixUSA

UK’s NICE says cost of Celgene’s Abraxane is not justified by its limited benefit

UK’s NICE says cost of Celgene’s Abraxane is not justified by its limited benefit

30-12-2014

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has today published…

AbraxaneCelgene CorpOncologyPharmaceuticalRegulationUK

FDA approves Bristol-Myers Squibb’s Opdivo for advanced melanoma

FDA approves Bristol-Myers Squibb’s Opdivo for advanced melanoma

23-12-2014

The US Food and Drug Administration yesterday granted accelerated approval to US pharma major Bristol-Myers…

Bristol-Myers SquibbKeytrudaMerck & CoOncologyOpdivoPharmaceuticalRegulationUSA

AstraZeneca’s Lynparza gains FDA approval

AstraZeneca’s Lynparza gains FDA approval

20-12-2014

The US Food and Drug Administration has granted accelerated approved for Anglo-Swedish drug major AstraZeneca’s…

AstraZenecaLynparzaOncologyPharmaceuticalRegulationUSA

Polaris Group receives orphan drug designation for ADI-PEG 20 from the FDA

Polaris Group receives orphan drug designation for ADI-PEG 20 from the FDA

19-12-2014

Privately-held Polaris Group has received orphan drug designation for ADI-PEG 20 (pegylated arginine…

ADI-PEG 20OncologyPharmaceuticalPolaris GroupRegulation

European Commission grants marketing authorization to AstraZeneca's Lynparza

European Commission grants marketing authorization to AstraZeneca's Lynparza

18-12-2014

Anglo-Swedish drug major AstraZeneca has received marketing authorization from the European Commission…

AstraZenecaLynparzaOncologyPharmaceuticalRegulation

Eisai's Halaven now available in Russia for advanced breast cancer

Eisai's Halaven now available in Russia for advanced breast cancer

18-12-2014

Halaven (eribulin) manufactured by Japanese drug major Eisai is now available in Russia.

EisaiHalavenOncologyPharmaceuticalRegulationRussia

FDA approves Ipsen's Somatuline for metastatic gastroentero pancreatic neuroendocrine tumors

FDA approves Ipsen's Somatuline for metastatic gastroentero pancreatic neuroendocrine tumors

17-12-2014

The US Food and Drug Administration has approved Somatuline Depot (lanreotide) injection 120mg, manufactured…

IpsenOncologyPharmaceuticalRegulationSomatulineUSA

UK’s NICE recommends Pfizer’s Inlyta for kidney cancer

UK’s NICE recommends Pfizer’s Inlyta for kidney cancer

16-12-2014

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

InlytaOncologyPfizerPharmaceuticalPricingRegulationUK

UK NICE partially backs Bayer’s Xofigo in preliminary assessment

UK NICE partially backs Bayer’s Xofigo in preliminary assessment

15-12-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) have recommended…

BayerOncologyPharmaceuticalPricingRegulationUKXofigo

Genentech files NDA for cobimetinib with Zelboraf in advanced melanoma

Genentech files NDA for cobimetinib with Zelboraf in advanced melanoma

15-12-2014

Genentech, the US biotech subsidiary of Swiss Pharma major Roche Group, has submitted a New Drug Application…

BiotechnologycobimetinibExelixisGenentechOncologyRegulationRocheUSAZelboraf

FDA approves third indication for Lilly’s Cyramza

FDA approves third indication for Lilly’s Cyramza

13-12-2014

The US Food and Drug Administration on Friday expanded the approved use of pharma major Eli Lilly’s…

CyramzaEli LillyOncologyPharmaceuticalRegulationUSA

Merck’s new Gardasil 9 gains backing from US FDA

Merck’s new Gardasil 9 gains backing from US FDA

11-12-2014

The US Food and Drug Administration yesterday approved pharma giant Merck & Co’s Gardasil 9-valent…

Gardasil 9Merck & CoOncologyPharmaceuticalRegulationUSAVaccines

FDA approves new indication for Amgen's Xgeva

FDA approves new indication for Amgen's Xgeva

08-12-2014

USA-based Amgen says the US Food and Drug Administration has approved a new indication for Xgeva (denosumab),…

AmgenBiotechnologyOncologyRare diseasesRegulationUSAXgeva

Roche's Gazyvaro and Bayer’s Adempas approved by Scottish Medicines Consortium

Roche's Gazyvaro and Bayer’s Adempas approved by Scottish Medicines Consortium

08-12-2014

The Scottish Medicines Consortium has decided to grant access to Gazyvaro (obinutuzumab), manufactured…

AdempasBayerCardio-vascularGazyvaroOncologyPharmaceuticalRegulationRoche

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