Regulation - Pharmaceutical, Daiichi Sankyo

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FDA review of CV risks for diabetics taking olmesartan not conclusive

FDA review of CV risks for diabetics taking olmesartan not conclusive

25-06-2014

The US Food and Drug Administration has completed its safety review and has found no clear evidence of…

BenicarCardio-vascularDaiichi SankyoDiabetesolmesartanPharmaceuticalRegulationUSA

Daiichi Sankyo launches blood thinner Efient in Japan

27-05-2014

Daiichi Sankyo said this morning that it has launched its anti-blood clotting drug Efient (prasugrel…

Cardio-vascularDaiichi SankyoEfientJapanMarkets & MarketingPharmaceuticalRegulation

Daiichi Sankyo files Savaysa for US approval; collaborates with Virtici and Celdara Medical

Daiichi Sankyo files Savaysa for US approval; collaborates with Virtici and Celdara Medical

10-01-2014

Japanese drug major Daiichi Sankyo has filed a New Drug Application for its investigational, oral, once-daily…

Cardio-vascularCeldara MedicalDaiichi SankyoedoxabanNorth AmericaPharmaceuticalRegulationResearchSavaysaUSAVirtici

Daiichi Sankyo submits edoxaban application to the EMA for stroke prevention

Daiichi Sankyo submits edoxaban application to the EMA for stroke prevention

08-01-2014

Japanese drug major Daiichi Sankyo (TYO: 4568) has submitted a Marketing Authorization Application to…

Asia-PacificCardio-vascularDaiichi SankyoedoxabanPharmaceuticalRegulation

Daiichi Sankyo files Ranmark to treat giant cell tumor of bone in Japan

29-08-2013

Japanese drug major Daiichi Sankyo (TYO: 4568) has filed an application for approval in Japan to manufacture…

AmgenAsia-PacificDaiichi SankyoOncologyPharmaceuticalPraliaRanmarkRegulation

Japan vaccines briefs: Gardasil and Cervarix; Daiichi Sankyo files NDA

21-06-2013

The Japanese Ministry of Health, Labor and Welfare has decided to withdraw its recommendation for a vaccination…

Asia-PacificCervarixDaiichi SankyoGardasilGlaxoSmithKlineMerck & CoPharmaceuticalRegulationVaccinesWomen's Health

Daiichi Sankyo files for Japanese approval of Prasugrel

18-06-2013

Japanese drug major Daiichi Sankyo (TYO: 4568) says that it has submitted a New Drug Application to the…

Asia-PacificCardio-vascularDaiichi SankyoEffientEli LillyPharmaceuticalprasugrelRegulation

US FDA sets new PDUFA action date for Vifor's Injectafer NDA

08-04-2013

Vifor Pharma, a unit of Switzerland's Galenica Group (SIX: GALN), says that its US partner, Luitpold…

Daiichi SankyoFerinjectGalenicaInjectaferLuitpold PharmaNorth AmericaPharmaceuticalRegulationVifor Pharma

Daiichi Sankyo updates on PRASFIT-Elective study, NDA filing

14-03-2013

Japanese drug major Daiichi Sankyo (TYO: 4568) says that the follow-up period for the Phase III PRASFIT-Elective…

Asia-PacificAspirinCardio-vascularDaiichi SankyoEffientPharmaceuticalprasugrelRegulationResearch

Daiichi Sankyo to file prasugrel in Japan next year, following strong results

25-09-2012

Japanese drug major Daiichi Sankyo (TYO: 4568) has announced data from the PRASFIT-ACS study, a double-blind…

Asia-PacificCardio-vascularDaiichi SankyoPharmaceuticalprasugrelRegulationResearch

Daiichi Sankyo files denosumab in Japan for osteoporosis

26-03-2012

Japanese drug major Daiichi Sankyo (TYO: 4568) revealed on Friday that it has filed for approval in Japan…

AmgenAnti-Arthritics/RheumaticsAsia-PacificDaiichi SankyodenosumabPharmaceuticalRegulation

Additional indications in Japan for Diagnogreen and Sawacillin

22-02-2012

Japanese drug major Daiichi Sankyo (TYO: 4568) says it has received approval in Japan for a supplemental…

Antibiotics and Infectious diseasesAsia-PacificAstellas PharmaDaiichi SankyoPharmaceuticalRegulationSawacillin

European approval for Roche skin cancer drug Zelboraf

21-02-2012

Swiss drug major Roche (ROG: SIX) says that the European Commission has approved Zelboraf (vemurafenib)…

Daiichi SankyoEuropeOncologyPharmaceuticalRegulationRocheZelboraf

Japanese approval for Regnite and Ranmark

18-01-2012

Japanese drug major Astellas Pharma (TYO: 4503) and USA-based XenoPort (Nasdaq: XNPT) revealed yesterday…

AmgenAsia-PacificAstellas PharmaAstraZenecaBiotechnologyDaiichi SankyodenosumabFinancialNeurologicalOncologyPharmaceuticalRanmarkRegniteRegulationXenoPort

Ranbaxy signs consent decree with US FDA over production practices

22-12-2011

India’s largest drugmaker Ranbaxy Laboratories (RANB: BO), which is 64% owned by Japan’s Daiichi…

Daiichi SankyoFinancialGenericsLegalNorth AmericaPharmaceuticalRanbaxy LaboratoriesRegulation

EMA recommends approval of Roche’s Zelboraf

19-12-2011

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

Daiichi SankyoEuropeOncologyPharmaceuticalRegulationRocheZelboraf

Backing for Japanese approval of Regnite, Ranmark and Cancidas

05-12-2011

USA-based XenoPort (Nasdaq: XNPT) saw its shares rise 3% to $4.73 on Friday, when the company said it…

Antibiotics and Infectious diseasesAsia-PacificCancidasDaiichi SankyodenosumabHorizantMerck & CoOncologyPharmaceuticalRegniteRegulationXenoPort

AstraZeneca’s blood thinner Brilinta/Brilique demonstrates cost effectiveness; new Nexium indication filed in Japan

24-10-2011

Data from eight countries shows that using Anglo-Swedish drug major AstraZeneca’s (LSE: AZN) Brilique/Brilinta…

AstraZenecaBrilintaBriliqueCardio-vascularDaiichi SankyoGastro-intestinalsNexiumPharmaceuticalPricingRegulation

Daiichi Sankyo admits supply problem with flu vaccine; gains approval for silodosin in China

23-09-2011

Japanese drug major Daiichi Sankyo (TYO: 4568) announced this week that its domestic subsidiary, Kitasato…

Asia-PacificDaiichi SankyoMarkets & MarketingOncologyPharmaceuticalRegulationsilodosinVaccines

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