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Daiichi Sankyo gets Japanese approval for Methylene Blue

05-01-2015

Japanese drug major Daiichi Sankyo has received approval in Japan for the manufacture and marketing of…

Daiichi SankyoHematologyJapanMethylene Blue InjectionPharmaceuticalProvepharmRegulation

US FDA advisory panel backs Daiichi Sankyo’s Savaysa for stroke risk and SEE

03-11-2014

A US Food and Drug advisory panel has voted in favor of the use of Japanese pharma major Daiichi Sankyo’s…

Cardio-vascularDaiichi SankyoedoxabanPharmaceuticalRegulationSavaysaUSA

Brilinta preferred over clopidogrel in latest AHA/ACC guideline

Brilinta preferred over clopidogrel in latest AHA/ACC guideline

06-10-2014

Anglo-Swedish pharma major AstraZeneca today confirmed that the American Heart Association (AHA) and…

AstraZenecaBrilintaCardio-vascularClopidogrelDaiichi SankyoEli LillyPharmaceuticalprasugrelRegulationSanofiticagrelorUSA

Daiichi Sankyo seeks wider indication for Cravit in Japan

Daiichi Sankyo seeks wider indication for Cravit in Japan

03-10-2014

Japanese drug major Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) in Japan…

Antibiotics and Infectious diseasesCravitDaiichi SankyoJapanPharmaceuticalRegulation

Added indication for Daiichi Sankyo’s Lixiana in Japan

Added indication for Daiichi Sankyo’s Lixiana in Japan

29-09-2014

The Japanese Ministry of Health, Labor and Welfare has granted approval for domestic pharma major Daiichi…

Cardio-vascularDaiichi SankyoJapanLixianaPharmaceuticalRegulation

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

04-07-2014

Japanese drug major Mitsubishi Tanabe Pharma has received approval to manufacture and market the SGLT2…

canagliflozinCanagluDaiichi SankyoDiabetesJapanMitsubishi TanabePharmaceuticalRegulationSanofi PasteurVaccines

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

Another ban by US FDA on a Ranbaxy production facility

Another ban by US FDA on a Ranbaxy production facility

24-01-2014

As if the Indian drug major has not had enough negative news from the US regulator, the US Food and Drug…

Asia-PacificDaiichi SankyoGenericsIndiaNorth AmericaProductionRanbaxy LaboratoriesRegulationUSA

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

Ranbaxy cleared to market branded generic of Aricept in Canada

Ranbaxy cleared to market branded generic of Aricept in Canada

08-01-2014

The Canadian subsidiary of Ranbaxy Laboratories has received approval to manufacture and market RAN-Donepezil…

AriceptCanadaDaiichi SankyoEisaiGenericsNeurologicalNorth AmericaRAN-DonepezilRanbaxy LaboratoriesRegulation

Ban on FDA-regulated drugs from Ranbaxy's Mohali plant

17-09-2013

There was another blow for India's largest drugmaker Ranbaxy Laboratories (BSE: 500359) yesterday (September…

Asia-PacificDaiichi SankyoGenericsNorth AmericaProductionRanbaxy LaboratoriesRegulation

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

Ranbaxy highlights its actions on improved business and quality assurance

23-05-2013

Indian drugmaker Ranbaxy Laboratories (BSE: 500359), whose US subsidiary was the subject of the biggest…

Daiichi SankyoGenericsManagementProductionRanbaxy LaboratoriesRegulation

US DoJ says Ranbaxy pleads guilty and agrees to pay $500 million in settlements

14-05-2013

In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA, a subsidiary…

Asia-PacificDaiichi SankyoFinancialGenericsLegalNorth AmericaProductionRanbaxy LaboratoriesRegulation

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

US FDA pulls 27 Ranbaxy ANDAs approvals under consent decree

23-08-2012

The Food and Drug Administration is withdrawing approval of 27 Abbreviated New Drug Applications (ANDAs)…

Antibiotics and Infectious diseasesDaiichi SankyoDiabetesGenericsNorth AmericaRanbaxy LaboratoriesRegulation

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

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