Regulation - Sanofi, North America

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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

US FDA calls for more trials on Genzyme’s Lemtrada

US FDA calls for more trials on Genzyme’s Lemtrada

30-12-2013

There was a significant disappointment this morning for French drug major Sanofi, when it revealed that…

BayerGenzymeLemtradaNeurologicalNorth AmericaPharmaceuticalRegulationSanofiUSA

FDA allows OTC of Sanofi’s Nasacort

FDA allows OTC of Sanofi’s Nasacort

13-10-2013

The US Food and Drug Administration has approved Sanofi’s Nasacort Allergy 24HR nasal spray as an over-the-counter…

ChattemNasacort AQNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySanofi

Sanofi reaches deal in rimonabant lawsuit

Sanofi reaches deal in rimonabant lawsuit

23-09-2013

French drug major Sanofi (Euronext; SAN) has reached a $40 million settlement in a US lawsuit accusing…

MetabolicsNorth AmericaRegulationSanofi

Sanofi temporarily pulls lixisenatide NDA in USA

12-09-2013

French drug major Sanofi (Euronext: SAN) this morning (September 12) announced its decision to withdraw…

DiabeteslixisenatideLyxumiaNorth AmericaPharmaceuticalRegulationSanofiZealand Pharma

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

FDA advisory committee backs approval of Sanofi drug for OTC

01-08-2013

The US Food and Drug Administration's Nonprescription Drugs Advisory Committee (NDAC) voted 10 to six,…

Nasacort AQNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySanofiTeva Pharmaceutical Industries

US FDA warns pregnant women to not use valproate migraine prevention medicines

07-05-2013

The US Food and Drug Administration is alerting health care providers and patients that medications including…

Abbott LaboratoriesGenericsNeurologicalNorth AmericaNoven PharmaceuticalsPharmaceuticalRegulationSanofivalproate Sodium Injection

US FDA accepts Sanofi's NDA for diabetes drug lixisenatide

19-02-2013

The US Food and Drug Administration has accepted for review French drug major Sanofi's (Euronext: SAN)…

DiabeteslixisenatideNorth AmericaPharmaceuticalRegulationSanofiZealand Pharma

Briefs: Sanofi to up stake in Regeneron; Bayer files for riociguat approval

12-02-2013

US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) saw its shares rise 4.8% to $173.84 in early trading…

BayerBiotechnologyEuropeFinancialMergers & AcquisitionsNorth AmericaPharmaceuticalRegeneronRegulationRespiratory and PulmonaryriociguatSanofi

FDA clears Sanofi and Isis' Kynamro for inherited cholesterol disorder

30-01-2013

The US Food and Drug Administration yesterday approved Sanofi (Euronext: SAN) subsidiary Genzyme's orphan…

BiotechnologyCardio-vascularGenzymeIsis PharmaceuticalsKynamroNorth AmericaPharmaceuticalRare diseasesRegulationSanofi

Genzyme says Lemtrada sBLA for MS accepted by FDA; reports on Aubagio

28-01-2013

French drug major Sanofi (Euronext: SAN) US biotech subsidiary Genzyme says that the US Food and Drug…

AubagioBiotechnologyGenzymeLemtradaMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalRegulationSanofi

US FDA lowers recommended dose for sleep drugs containing zolpidem

11-01-2013

The US Food and Drug Administration yesterday announced it is requiring the manufacturers of Ambien,…

AmbienAmbien CREdluarMedaNeurologicalNorth AmericaNovaDel PharmaPharmaceuticalRegulationSanofizolpidemZolpiMist

Health Canada approves Vertex' Kalydeco; and Sanofi Pasteur's Menactra

03-12-2012

Vertex Pharmaceuticals (Nasdaq: VRTX) says that Health Canada has approved Kalydeco (ivacaftor), the…

BiotechnologyKalydecoMenactraNorth AmericaPharmaceuticalRare diseasesRegulationSanofiSanofi PasteurVaccinesVertex

FDA advisory panel votes 9 to 6 to approve Genzyme's Kynamro

19-10-2012

The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory yesterday voted by…

BiotechnologyCardio-vascularGenzymeIsis PharmaceuticalsKynamroNorth AmericaPharmaceuticalRare diseasesRegulationSanofi

US FDA agrees to review Sanofi Pasteur's new quadrivalent influenza vaccine

18-10-2012

Sanofi Pasteur, the vaccines division of Sanofi (Euronext: SAN) says it has filed a supplemental Biologics…

Anti-viralsNorth AmericaPharmaceuticalRegulationSanofiSanofi PasteurVaccines

Watson gets FDA approval for generic Sanctura XR and Avapro

14-10-2012

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) has received approval from the US Food and Drug…

AllerganAvaproCardio-vascularGenericsGenito-urinaryNorth AmericaRegulationSanctura XRSanofiWatson Pharmaceuticals

Bayer's Stivarga races to FDA approval on the heels of Zaltrap

07-10-2012

The earlier than expected US Food and Drug Administration approval of German drug major Bayer's (BAYN:…

BayerBiotechnologyMarkets & MarketingNorth AmericaOncologyOnyx PharmaceuticalsPharmaceuticalregorafenibRegulationSanofiStivargaZaltrap

FDA thumbs up for Sanofi's MS drug Aubagio

13-09-2012

As has been largely expected, the US Food and Drug Administration yesterday approved marketing of French…

AubagioBiotechnologyGenzymeNeurologicalNorth AmericaPharmaceuticalRegulationSanofi

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