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US biosimilar approvals poised to grow, but market uptake faces challenges, says Tufts CSDD

05-03-2015

Biosimilar approvals in the USA are expected to increase during the next five years, but safety concerns…

BiosimilarsBiotechnologyFinancialMarkets & MarketingRegulationUSA

US FDA expands use of Bristol-Myers’ Opdivo to NSCLC

US FDA expands use of Bristol-Myers’ Opdivo to NSCLC

05-03-2015

The US Food and Drug Administration late yesterday expanded the approved use of pharma major Bristol-Myers…

BiotechnologyBristol-Myers SquibbOncologyOpdivoRegulationUSA

FDA accepts Bayer's BLA for hemophilia A agent Kovaltry

FDA accepts Bayer's BLA for hemophilia A agent Kovaltry

04-03-2015

The US Food and Drug Administration has accepted German pharma major Bayer’s Biologics License Application…

BAY 81-8973BayerBiotechnologyHematologyKovaltryRegulationUSA

FDA formally accepts Actelion's NDA for Uptravi

FDA formally accepts Actelion's NDA for Uptravi

04-03-2015

Switzerland-based Actelion, Europe’s largest biotech company, says that the US Food and Drug Administration…

ActelionBiotechnologyRegulationRespiratory and PulmonaryselexipagUptraviUSA

Oncolytics Biotech gains third orphan status for Reolysin

Oncolytics Biotech gains third orphan status for Reolysin

03-03-2015

Canada’s Oncolytics Biotech revealed today that the US Food and Drug Administration has granted Orphan…

BiotechnologyOncologyOncolytics BiotechRare diseasesRegulationReolysinUSA

Cardio3 BioSciences milestone in regulatory path for C-Cure registration in EU

Cardio3 BioSciences milestone in regulatory path for C-Cure registration in EU

03-03-2015

Belgian cell therapy specialist Cardio3 BioSciences has received a Pediatric Investigation Plan (PIP)…

BiotechnologyC-CureCardio-vascularCardio3 BioSciencesEuropeRegulation

NICE draft guidance backs Gilead’s Harvoni for treating chronic hepatitis C

NICE draft guidance backs Gilead’s Harvoni for treating chronic hepatitis C

03-03-2015

The National Institute for Health and Care Excellence (NICE), the medicines cost watchdog for England,…

Anti-viralsBiotechnologyGilead SciencesHarvoniPricingRegulationUK

Positive Ph III results for Portola’s Xarelto antidote andexanet alfa

02-03-2015

USA-based Portola Pharmaceuticals saw its shares jump 7.2% to $40.83 after it announced positive results…

andexanet alfaBayerBiotechnologyCardio-vascularPortola PharmaceuticalsRegulationResearchUSA

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