Regulation - 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

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

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

1 to 25 of 27 results

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