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US FDA eases clinical hold on Geron’s imetelstat

US FDA eases clinical hold on Geron’s imetelstat

21-03-2014

There was a touch of good news yesterday for Geron Corp, after the US Food and Drug Administrated partially…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

12-03-2014

USA-based Geron Corp saw its shares plunge 59% to $1.79 when the company revealed that it had received…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

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

Titan Pharma in general agreement with FDA on pathway for Probuphine

Titan Pharma in general agreement with FDA on pathway for Probuphine

04-03-2014

California, USA-based Titan Pharma and its partner, Braeburn Pharmaceuticals, have agreed in principle…

Braeburn PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalProbuphineRegulationResearchTitan PharmaceuticalsUSA

FDA to review heart failure risk with AstraZeneca diabetes drug

FDA to review heart failure risk with AstraZeneca diabetes drug

12-02-2014

The US Food and Drug Administration has requested clinical trial data from Anglo-Swedish drug major AstraZeneca,…

AstraZenecaDiabetesKombiglyzeNorth AmericaOnglyzaPharmaceuticalRegulationResearchUSA

FDA investigating risk of stroke, heart attack and death with testosterone products

FDA investigating risk of stroke, heart attack and death with testosterone products

03-02-2014

The US Food and Drug Administration said on Friday that it is investigating the risk of stroke, heart…

AbbVieActavisAndrodermAndroGelAxironEli LillyMen's HealthNorth AmericaPharmaceuticalRegulationResearchTestosteroneUSA

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

US drug approvals lower than previously reported; new study

10-01-2014

The overall success rate for drugs moving through clinical trials to US Food and Drug Administration…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearchUSA

US global share of biomedical research spending declines, as Asia gains

02-01-2014

The USA’s global share of biomedical research spending fell from 51% in 2007 to 45% in 2012, while…

Asia-PacificChinaFinancialNorth AmericaPharmaceuticalRegulationResearchUSA

Takeda stops development of diabetes candidate fasiglifam; PDUFA date for vedolizumab extended

Takeda stops development of diabetes candidate fasiglifam; PDUFA date for vedolizumab extended

27-12-2013

Japan’s largest drugmaker Takeda Pharmaceutical has decided voluntarily to terminate the development…

DiabetesfasiglifamGastro-intestinalsNorth AmericaPharmaceuticalRegulationResearchTakeda PharmaceuticalsUSAvedolizumab

New Ph III data support early 2014 filing for Cubist’s ceftolozane/tazobactam

New Ph III data support early 2014 filing for Cubist’s ceftolozane/tazobactam

17-12-2013

US drugmaker Cubist Pharmaceuticals saw its shares jump 8.3% to $68 in premarket trading yesterday, when…

Antibiotics and Infectious diseasesceftolozoneCubist PharmaceuticalsEuropeNorth AmericaPharmaceuticalRegulationResearchtazobactam

OncoMed CEO presses for better environment for biopharma innovation, at House hearings

13-12-2013

The case for encouraging biopharma innovation was presented yesterday at the US House Committee on Oversight…

BiotechnologyNorth AmericaOncoMed PharmaceuticalsPoliticsRegulationResearch

Orexigen to resubmit US NDA for obesity drug Contrave

26-11-2013

Along with presenting new data for its weight loss drug candidate Contrave (naltrexone SR and bupropion…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulationResearchTakeda Pharmaceuticals

“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

Sarepta plunges as FDA questions eteplirsen trial results

Sarepta plunges as FDA questions eteplirsen trial results

12-11-2013

Shares of US RNA-based drug developer Sarepta Therapeutics plummeted in pre-market trading on November…

BiotechnologydrisaperseneteplirsenGlaxoSmithKlineNorth AmericaRare diseasesRegulationResearchSarepta Therapeutics

Curis plunges on negative CUCD-427 news; 3rd-qtr loss down

07-11-2013

Oncology focussed US biotech firm Curis saw its shares sink 21% to $3.08, after it revealed receipt of…

BiotechnologyCUCD-427CurisFinancialNorth AmericaOncologyRegulationResearch

US orphan status for Pharmalink’s Busulipo

US orphan status for Pharmalink’s Busulipo

29-10-2013

Swedish specialty pharma group Pharmalink says its product Busulipo, (busulfan), a best-in-class conditioning…

BusulipoNefeconNephrology and HepatologyNorth AmericaOncologyPharmaceuticalPharmaLinkRegulationResearch

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

25-10-2013

Merck & Co yesterday provided an overview of the clinical trial program for V503, the company’s investigational…

Merck & CoNorth AmericaPharmaceuticalRegulationResearchV503Vaccines

Ariad stops Ph III Iclusing trial on blood clot woes

18-10-2013

US biotech firm Ariad Pharmaceuticals’took another tumble, falling 35% to $2.91, as the company said…

Ariad PharmaceuticalsBiotechnologyIclusigNorth AmericaOncologyRegulationResearch

FDA clinical hold on Iclusig sees Ariad stock go into free-fall

FDA clinical hold on Iclusig sees Ariad stock go into free-fall

10-10-2013

US drugmaker Ariad Pharmaceuticals saw its shares plunge 59% to $6.99 yesterday, wiping $2 billion off…

Ariad PharmaceuticalsBiotechnologyIclusigNorth AmericaOncologyRegulationResearch

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

PhRMA calls for regulatory environment to support rare disease research

PhRMA calls for regulatory environment to support rare disease research

08-10-2013

US biopharmaceutical research companies are developing 452 new medicines for rare diseases, according…

North AmericaPharmaceuticalRare diseasesRegulationResearch

Positive results with MannKind's type 1 diabetes drug please investors

15-08-2013

There was good news for loss-making US drugmaker MannKind (Nasdaq: MNKD), when the company announced…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationResearch

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