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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

US FDA approves new indication for Incyte’s Jakafi

US FDA approves new indication for Incyte’s Jakafi

05-12-2014

The US Food and Drug Administration yesterday approved a new use for Incyte Corp’s Jakafi (ruxolitinib)…

BiotechnologyIncyteJakafiOncologyRegulationUSA

US FDA grants earlier approval for Amgen’s Blincyto for rare form of lymphoblastic leukemia

US FDA grants earlier approval for Amgen’s Blincyto for rare form of lymphoblastic leukemia

04-12-2014

Ahead of the anticipated decision date, the US Food and Drug Administration yesterday approved Blincyto…

AmgenBiotechnologyblinatumomabBlincytoOncologyRegulationUSA

Puma shares plummet as it delays NDA filing

Puma shares plummet as it delays NDA filing

03-12-2014

Puma Biotechnology will delay the filing of its New Drug Application (NDA) for the approval of PB272…

BiotechnologyneratinibOncologyPuma BiotechnologyRegulationUSA

FDA accepts NDA filing from AstraZeneca for Iressa

FDA accepts NDA filing from AstraZeneca for Iressa

02-12-2014

The US Food and Drug Administration has accepted for filing the New Drug Application from Iressa (gefitinib)…

AstraZenecaIressaOncologyPharmaceuticalRegulationUK

NICE reverses October decision and approves Roche's Gazyvaro

NICE reverses October decision and approves Roche's Gazyvaro

02-12-2014

The UK’s National Institute for Health and Care Excellence (NICE) has reversed its decision on Gazyvaro…

GazyvaroOncologyPharmaceuticalRegulationRocheUK

Janssen and Pharmacyclics submit EMA application to expand indication for Imbruvica

Janssen and Pharmacyclics submit EMA application to expand indication for Imbruvica

01-12-2014

US health care giant Johnson & Johnson’s Belgium-based subsidiary Janssen-Cilag International has submitted…

EuropeImbruvicaJanssen-CilagOncologyPharmaceuticalPharmacyclicsRegulation

Boehringer’s Vargatef gains approval in EU for lung cancer

Boehringer’s Vargatef gains approval in EU for lung cancer

28-11-2014

The European Commission has granted EU marketing authorization for German family-owned pharma major Boehringer…

Boehringer IngelheimEuropeOncologyPharmaceuticalRegulationVargatef

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

Janssen submits NDA for Yondelis in soft tissue sarcoma

Janssen submits NDA for Yondelis in soft tissue sarcoma

25-11-2014

US health care giant Johnson & Johnson’s subsidiary Janssen Research & Development has submitted a…

Janssen Research and DevelopmentOncologyPharmaceuticalRegulationUSAYondelis

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

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