Regulation - North America, Cardio-vascular

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US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

07-04-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

US FDA advisory panel votes against approval of Novartis’ AHF drug

US FDA advisory panel votes against approval of Novartis’ AHF drug

28-03-2014

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee yesterday voted…

Cardio-vascularNorth AmericaNovartisPharmaceuticalReasanzRegulationserelaxinUSA

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

16-03-2014

The US Food and Drug Administration has approved pharma major Bristol-Myers Squibb’s supplemental New…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulationUSA

FDA probing Regeneron and Sanofi’s investigational drug alirocumab

FDA probing Regeneron and Sanofi’s investigational drug alirocumab

10-03-2014

French drug major Sanofi has revealed in a regulatory filing that the US Food and Drug Administration…

alirocumabCardio-vascularNorth AmericaPharmaceuticalRegeneronRegulationResearchSanofiUSA

Actavis challenges Multaq and Colcrys patents

02-03-2014

Ireland-headquartered generic drugmaker Actavis revealed on Friday (February 28) that French pharma giant…

ActavisAnti-Arthritics/RheumaticsCardio-vascularColcrysGenericsLegalMultaqNorth AmericaPatents & Trade marksRegulationSanofiTakeda PharmaceuticalsUSA

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

14-02-2014

There was further negative news for Germany’s Bayer and partner US health care giant Johnson & Johnson,…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

17-01-2014

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted against…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

FDA advisory panel votes to approve Merck & Co’s vorapaxar

FDA advisory panel votes to approve Merck & Co’s vorapaxar

16-01-2014

There was a positive outcome for US pharma giant Merck & Co yesterday, when a US Food and Drug Administration…

Cardio-vascularMerck & CoNorth AmericaPharmaceuticalRegulationUSAvorapaxarZontivity

Surprise FDA advisory panel backing for Chelsea’s Northera

Surprise FDA advisory panel backing for Chelsea’s Northera

15-01-2014

A US Food and Drug Administration advisory panel has voted 16-one to recommend approval of US biotech…

BiotechnologyCardio-vascularChelsea TherapeuticsNorth AmericaNortheraRegulationUSA

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

14-01-2014

US drug giant Merck & Co says it has started a rolling submission to the US Food and Drug Administration…

Cardio-vascularMerck & CoMK-3475North AmericaOncologyPharmaceuticalRegulationUSAvorapaxarZontivity

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

“Breakthrough Therapy” status for Portola’s andexanet alfa

25-11-2013

USA-based Portola Pharmaceuticals has been granted “Breakthrough Therapy” designation by the US Food…

andexanet alfaBayerBristol-Myers SquibbCardio-vascularEliquisNorth AmericaPharmaceuticalPortola PharmaceuticalsRegulationResearchXarelto

FDA says PCSK9 inhibitors may not require outcome studies

FDA says PCSK9 inhibitors may not require outcome studies

18-11-2013

The US Food and Drug Administration has said that pharma companies developing PCSK9 inhibitors will not…

Cardio-vascularNorth AmericaPharmaceuticalRegulationUSA

Actelion receives Health Canada approval of Opsumit for PAH

Actelion receives Health Canada approval of Opsumit for PAH

13-11-2013

Swiss biotech firm Actelion (SIX: ATLN) says that Canada’s regulator Health Canada has approved its…

ActelionCanadaCardio-vascularNorth AmericaOpsumitPharmaceuticalRegulation

US FDA gives nod to Actelion’s PAH drug Opsumit

US FDA gives nod to Actelion’s PAH drug Opsumit

21-10-2013

The US Food and Drug Administration has approved Actelion's pulmonary arterial hypertension drug Opsumit…

ActelionBiotechnologyCardio-vascularNorth AmericaOpsumitRegulation

FDA advisory panel goes negative on Amarin’s Vascepa

FDA advisory panel goes negative on Amarin’s Vascepa

17-10-2013

US biotech firm Amarin revealed yesterday that the US Food and Drug Administration Endocrinologic and…

AmarinBiotechnologyCardio-vascularNorth AmericaRegulationVascepa

FDA approves Bayer’s Adempas; firm accelerates drug candidates

FDA approves Bayer’s Adempas; firm accelerates drug candidates

09-10-2013

The US Food and Drug Administration late yesterday approved Adempas (riociguat), developed by German…

AdempasBayerCardio-vascularcopanlisibfinerenoneNorth AmericaOncologyPharmaceuticalRegulationResearchRespiratory and PulmonaryWomen's Health

Lyxumia's delayed entrance into US anti-diabetes drug market could prove successful in the future, says GlobalData's analyst

18-09-2013

French drug major Sanofi's (Euronext: SAN) decision to withdraw Lyxumia's (lixisenatide)...

BiotechnologyCardio-vascularDiabetesLyxumiaNorth AmericaPharmaceuticalRegulationResearchSanofi

US FDA accepts Epanova NDA filing

18-09-2013

Anglo-Swedish drug major AstraZeneca (LSE: AZN) today announced that the US Food and Drug Administration…

AstraZenecaCardio-vascularEpanovaNorth AmericaOmthera PharmaceuticalsPharmaceuticalRegulation

Pradaxa sNDA for DVT and PE accepted by FDA

28-08-2013

The US Food and Drug Administration has accepted for review German independent drug major Boehringer…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulation

FDA should warn against prolonged use of Plavix for stent patients, says US consumer group

21-08-2013

The US Food and Drug Administration should warn patients and doctors that taking the widely prescribed…

Bristol-Myers SquibbCardio-vascularNorth AmericaPharmaceuticalPlavixRegulationSanofi

US FDA further delays Chelsea's Northera

29-07-2013

US biotech firm Chelsea Therapeutics (Nasdaq: CHTP) has received acknowledgment of its resubmitted New…

BiotechnologyCardio-vascularChelsea TherapeuticsNorth AmericaNortheraRegulation

Merck & Co's NDA for vorapaxar accepted for standard review by US FDA

25-07-2013

US pharma giant Merck & Co (NYSE: MRK) has said the New Drug Application (NDA) for its once-troubled…

Cardio-vascularMerck & CoNorth AmericaPharmaceuticalRegulationvorapaxar

US FDA accepts Bristol-Myers/Pfizer' Eliquis sNDA

12-07-2013

US pharma major Bristol-Myers Squibb (NYSE: BMY) and behemoth Pfizer (NYSE: PFE) announced that the US…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulation

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