Regulation - North America, Anti-Arthritics/Rheumatics

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Teva gains approval for generic Evista in the USA

Teva gains approval for generic Evista in the USA

04-03-2014

Israel-based Teva Pharmaceutical Industries says it has received approval from the US Food and Drug Administration…

Anti-Arthritics/RheumaticsEli LillyEvistaGenericsNorth AmericaRegulationTeva Pharmaceutical IndustriesUSA

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 approves Anika’s Monovisc for osteoarthritis pain of the knee

26-02-2014

US drugmaker Anika Therapeutics has received marketing approval for Monovisc from the US Food and Drug…

Anika TherapeuticsAnti-Arthritics/RheumaticsDePuyMonoviscNorth AmericaPharmaceuticalRegulationUSA

Health Canada clears AbbVie’s Humira for UC

Health Canada clears AbbVie’s Humira for UC

28-11-2013

In what is now the eighth indication in Canada for its top-selling drug Humira (adalimumab), US drugmaker…

AbbVieAnti-Arthritics/RheumaticsGastro-intestinalsHumiraNorth AmericaPharmaceuticalRegulation

Genentech’s SC Actemra approved by US FDA for severe RA

Genentech’s SC Actemra approved by US FDA for severe RA

22-10-2013

Genentech has announced that the US Food and Drug Administration has approved a subcutaneous formulation…

ActemraAnti-Arthritics/RheumaticsGenentechNorth AmericaPharmaceuticalRegulationRoche

US FDA approved auto-injector Otrexup from Antares Pharma for RA

US FDA approved auto-injector Otrexup from Antares Pharma for RA

15-10-2013

Antares Pharma has announced the approval of Otrexup (methotrexate) injection by the US Food and Drug…

Antares PharmaAnti-Arthritics/RheumaticsBiotechnologyNorth AmericaOtrexupRegulation

UCB’s Cimzia granted additional indication by US FDA

UCB’s Cimzia granted additional indication by US FDA

30-09-2013

UCB revealed today that the US Food and Drug Administration has approved its currently marketed drug…

Anti-Arthritics/RheumaticsCimziaNorth AmericaPharmaceuticalRegulationUCB

US FDA warns of hepatitis B reactivation risk with Arzerra and Rituxan

US FDA warns of hepatitis B reactivation risk with Arzerra and Rituxan

26-09-2013

The US Food and Drug Administration has approved changes to the prescribing information of the immune-suppressing…

Anti-Arthritics/RheumaticsArzerraBiogen IdecGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationRituxanRoche

Johnson & Johnson's Stelara gains FDA approval for psoriatic arthritis

24-09-2013

Janssen Research & Development announced that the US Food and Drug Administration has approved Stelara…

Anti-Arthritics/RheumaticsBiotechnologyJanssen BiotechNorth AmericaRegulationStelara Injection

US FDA accepts Pennsaid 2% NDA for review

22-08-2013

The US Food and Drug Administration has accepted for filing US drugmaker Mallinckrodt's (NYSE: MNK) New…

Anti-Arthritics/RheumaticsGenericsMallinckrodtNorth AmericaNuvo ResearchPennsaidPharmaceuticalRegulation

Nuvo's partner Mallinckrodt to resubmit osteoarthritis treatment to US FDA

24-07-2013

Canada's Nuvo Research (TSX: NRI) says that its licensing partner Mallinckrodt (NYSE: MNK) has successfully…

Anti-Arthritics/RheumaticsCovidienMallinckrodtNorth AmericaNuvo ResearchPennsaidPharmaceuticalRegulation

Simponi ARIA cleared by US FDA

19-07-2013

US health care giant Johnson & Johnson's (NYSE: JNJ) Janssen Biotech subsidiary has received US Food…

Anti-Arthritics/RheumaticsBiotechnologyJanssen BiotechJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi ARIA

Novartis' Ilaris gets new indication of childhood arthritis from US FDA

10-05-2013

Swiss pharmaceutical major Novartis (NIVN: VX) said this morning (May 10) that the US Food and Drug Administration…

Anti-Arthritics/RheumaticsNorth AmericaPharmaceuticalRare diseasesRegulation

Regulatory briefs on Bayer's Stivarga, Boehringer/Lilly's empagliflozin and Pfizer's Xeljanz

26-03-2013

Drug regulator Health Canada has approved German drug major Bayer's Stivarga (regorafenib tablets), indicated…

Anti-Arthritics/RheumaticsAsia-PacificBayerBiotechnologyBoehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaOncologyPfizerPharmaceuticalRegulationStivargaXeljanz

News briefs: Pfizer's filiburvir; Sanofi's Plavix; EMA sued over transparency

11-03-2013

Among a batch of news reported over the weekend, US drugs behemoth Pfizer (NYSE: PFE) has halted development…

AbbVieAnti-Arthritics/RheumaticsAnti-viralsBiotechnologyCardio-vascularEuropefiliburvirHumiraInterMuneNorth AmericaPfizerPharmaceuticalPlavixRegulationResearchSanofi

UCB files for US and EU approval for Cimzia for psoriatic arthritis and axial spondyloarthritis

20-02-2013

Belgium's largest drugmaker, UCB (Euronext Brussels: UCB) says it has made two new regulatory filings…

Anti-Arthritics/RheumaticsCimziaEuropeNorth AmericaPharmaceuticalRegulationUCB

Janssen files Stelara for active psoriatic arthritis in USA and EU

07-12-2012

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen yesterday submitted a supplemental…

Anti-Arthritics/RheumaticsBiotechnologyEuropeJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationStelara Injection

FDA approves Pfizer's Xeljanz for rheumatoid arthritis

07-11-2012

Having in the summer put back its "action date" due to a request for additional analysis of the existing…

Anti-Arthritics/RheumaticsNorth AmericaPfizerPharmaceuticalRegulationtofacitinibXeljanz

FDA Approves Abraxane for NSCLC and expands indication for Actemra

15-10-2012

The US Food and Drug Administration on Friday approved biotech firm Celgene's (Nasdaq: CELG) Abraxane…

AbraxaneActemraAnti-Arthritics/RheumaticsBiotechnologyCelgeneGenentechNorth AmericaOncologyPharmaceuticalRegulationRoche

Bristol-Myers' subcutaneous Orencia OKed in EU; Biologics for RA

07-10-2012

US drug major Bristol-Myers Squibb (NYSE: BMY) announced on Friday that the European Commission has granted…

Abbott LaboratoriesAmgenAnti-Arthritics/RheumaticsBiotechnologyBristol-Myers SquibbEnbrelEuropeHumiraMarkets & MarketingNorth AmericaOrenciaPfizerPharmaceuticalRegulation

Amgen's Prolia gets FDA nod for men with osteoporosis

24-09-2012

The US Food and Drug Administration last week approved a new indication for world biotech leader Amgen's…

AmgenAnti-Arthritics/RheumaticsBiotechnologyMen's HealthNorth AmericaProliaRegulation

Janssen files BLA for IV form of Simponi for moderate-to-severe RA

20-09-2012

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech has submitted a Biologics…

Anti-Arthritics/RheumaticsBiotechnologyJanssen BiotechJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi Injection

Abbott's Humira gains FDA panel backing for wider use

29-08-2012

The US Food and Drug Administration's Gastrointestinal Drugs Advisory Committee yesterday voted by 15…

Abbott LaboratoriesAnti-Arthritics/RheumaticsBiotechnologyGastro-intestinalsHumiraNorth AmericaPharmaceuticalRegulation

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