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Bristol-Myers to file Opdivo BLA earlier than expected

Bristol-Myers to file Opdivo BLA earlier than expected

10-07-2014

Following discussions with the US Food and Drug Administration, Bristol-Myers Squibb is planning a third…

Bristol-Myers SquibbnivolumabOncologyOpdivoPharmaceuticalRegulationUSA

$25 million milestone for Incyte on Japanese approval of Jakavi

$25 million milestone for Incyte on Japanese approval of Jakavi

08-07-2014

US biopharma company Incyte says it has earned a $25 million milestone payment from Swiss drug major…

BiotechnologyBusiness FinanceBusiness FinanceFinancialIncyteJakaviJapanMajorMedicineNovartisOncologyRegulationRuxolitinib

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

CASI granted Orphan Drug designation in treatment of hepatocellular carcinoma

CASI granted Orphan Drug designation in treatment of hepatocellular carcinoma

07-07-2014

US-based pharmaceutical company CASI, which develops therapeutics for the treatment of cancer and other…

CASIENMD-2076Hepatocellular carcinomaOncologyPharmaceuticalRegulationUSA

GSK receives EU approval for Mekinist for melanoma

GSK receives EU approval for Mekinist for melanoma

04-07-2014

The European Commission has granted marketing authorization for UK pharma giant GlaxoSmithKline’s Mekinist…

EuropeGlaxoSmithKlineMekinistOncologyPharmaceuticalRegulation

Japan first to approve Roche’s lung cancer drug alectinib

Japan first to approve Roche’s lung cancer drug alectinib

04-07-2014

The Japanese Ministry of Health, Labor and Welfare has approved Swiss pharma major Roche’s alectinib…

alectinibJapanOncologyPharmaceuticalRegulationRoche

FDA approves Spectrum’s Beleodaq for PTCL

FDA approves Spectrum’s Beleodaq for PTCL

04-07-2014

Under its accelerated approval program, the US Food and Drug Administration late yesterday cleared Spectrum…

BeleodaqbelinostatOncologyPharmaceuticalRegulationSpectrum PharmaceuticalsTopotargetUSA

EU approval for GSK and Genmab’s Arzerra as first-line CLL therapy

EU approval for GSK and Genmab’s Arzerra as first-line CLL therapy

03-07-2014

The European Commission has granted marketing authorization for a new indication for the use of UK pharma…

ArzerraEuropeGenmabGlaxoSmithKlineOncologyPharmaceuticalRegulation

Eisai’s breast cancer drug Halaven receives MAA in Europe

Eisai’s breast cancer drug Halaven receives MAA in Europe

03-07-2014

The European Commission has issued Marketing Authorization Approval (MAA) for Halaven (eribulin) from…

EisaiEuropeHalavenOncologyPharmaceuticalRegulation

Breakthrough status for Amgen’s blinatumomab in ALL

01-07-2014

USA-based Amgen, the world's largest independent biotech firm, says that the US Food and Drug Administration…

AmgenBiotechnologyblinatumomabOncologyRegulationUSA

Ipsen files sNDA for Somatuline for GEP-NETs

Ipsen files sNDA for Somatuline for GEP-NETs

01-07-2014

French drugmaker Ipsen has submitted a Supplemental New Drug Application to the US Food and Drug Administration…

IpsenOncologyPharmaceuticalRegulationSomatulineUSA

EMA accepts Merck’s pembrolizumab MAA for review

EMA accepts Merck’s pembrolizumab MAA for review

01-07-2014

US pharma giant Merck & Co says that the European Medicines Agency has accepted for review a Marketing…

EuropeMerck & CoOncologypembrolizumabPharmaceuticalRegulation

Positive data on Merck & Co’s nausea drug Emend Ph III trial in children

Positive data on Merck & Co’s nausea drug Emend Ph III trial in children

30-06-2014

Positive results have been announced by US pharma giant Merck & Co from a global, investigational Phase…

EmendMerck & CoOncologyPharmaceuticalRegulationResearch

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

Eisai files first marketing application for lenvatinib in Japan

Eisai files first marketing application for lenvatinib in Japan

26-06-2014

Japanese pharma major Eisai said today that it has submitted its first marketing authorization application…

EisaiJapanlenvatinibOncologyPharmaceuticalRegulation

Negative view from FDA advisory for AstraZeneca’s olaparib

Negative view from FDA advisory for AstraZeneca’s olaparib

26-06-2014

There was disappointment for Anglo-Swedish pharma major AstraZeneca yesterday when a US Food and Drug…

AstraZenecaLynparzaolaparibOncologyPharmaceuticalRegulationUSA

FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication

FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication

23-06-2014

The US Food and Drug Administration is warning that the intravenous chemotherapy drug docetaxel contains…

docetaxelOncologyPharmaceuticalRegulationUSA

Bayer’s Nexavar cleared in Japan for differentiated thyroid cancer

Bayer’s Nexavar cleared in Japan for differentiated thyroid cancer

20-06-2014

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved German pharma major Bayer’s oral…

BayerJapanNexavarOncologyPharmaceuticalRegulation

UK NICE to hold oral appeal hearing for Ferring’s Firmagon

UK NICE to hold oral appeal hearing for Ferring’s Firmagon

18-06-2014

Privately-held Switzerland-headquartered drugmaker Ferring Pharmaceuticals confirmed today that its drug…

Ferring PharmaceuticalsFirmagonOncologyPharmaceuticalRegulationUK

Gardasil approved in Europe for the prevention of anal cancer

Gardasil approved in Europe for the prevention of anal cancer

18-06-2014

Sanofi Pasteur MSD says that the European Commission has granted marketing authorization for the use…

EuropeGardasilHPVOncologyPharmaceuticalRegulationSanofi Pasteur MSD

US orphan status for Mirati’s mocetinostat and Alexion’s Soliris

US orphan status for Mirati’s mocetinostat and Alexion’s Soliris

17-06-2014

USA-based Mirati Therapeutics has been granted Orphan Drug designation by the US Food and Drug Administration…

BiotechnologyOncologyRare diseasesRegulation

Celgene exercises option for Agios Pharma’s AG-221

Celgene exercises option for Agios Pharma’s AG-221

17-06-2014

Metabolism specialist Agios Pharmaceuticals says that its partner, biotech major Celgene Corp, has exercised…

AG-221Agios PharmaceuticalsBiotechnologyCelgeneLicensingOncologyRegulationResearchUSA

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