Regulation - Regulation, BioMarin Pharmaceutical

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Extended US market exclusivity for BioMarin's rare disease drug Kuvan

14-04-2014

US drugmaker BioMarin Pharmaceutical says that the Food and Drug Administration has granted Kuvan (sapropterin…

BioMarin PharmaceuticalKuvanNorth AmericaPharmaceuticalRare diseasesRegulationUSA

Positive CHMP opinion for BioMarin’s Vimizim for Morquio A syndrome

Positive CHMP opinion for BioMarin’s Vimizim for Morquio A syndrome

21-02-2014

BioMarin Pharmaceutical says that the European Medicines Agency’s Committee for Medicinal Products…

BioMarin PharmaceuticalEuropePharmaceuticalRare diseasesRegulationVimizim

FDA approves Vimizim to treat rare congenital enzyme disorder

FDA approves Vimizim to treat rare congenital enzyme disorder

17-02-2014

The US Food and Drug Administration on Friday (February 14) approved BioMarin Pharmaceutical’s Vimizim…

BioMarin PharmaceuticalNorth AmericaPharmaceuticalRare diseasesRegulationUSAVimizim

FDA committee recommends approval for BioMarin's Vimizim

FDA committee recommends approval for BioMarin's Vimizim

20-11-2013

A US Food and Drug Administration panel has voted in favor of approval of Vimizim for the treatment of…

BioMarin PharmaceuticalNorth AmericaPharmaceuticalRare diseasesRegulationUSAVimizim

Briefs: BioMarin files Vimizim in Brazil; Kyowa Hakko submits KRN125 in Japan; Insmed's Arikace update

01-07-2013

USA-based BioMarin Pharmaceutical (Nasdaq: BMRN) has submitted the Vimizim (BMN-110, elosulfase alfa)…

Asia-PacificBioMarin PharmaceuticalBiotechnologyInsmedKRN125Kyowa Hakko KirinPharmaceuticalRegulationResearchSouth AmericaVimizim

BioMarin's Vimizim BLA accepted by FDA and MAA validated by EMA

30-05-2013

US drugmaker BioMarin Pharmaceutical (Nasdaq: BMRN) says that the Food and Drug Administration has accepted…

BioMarin PharmaceuticalEuropeNorth AmericaPharmaceuticalRare diseasesRegulationVimizim

BioMarin files BLA for Vimizim in USA

02-04-2013

US drugmaker BioMarin Pharmaceutical (Nasdaq: BMRN) has submitted a Biologics License Application (BLA)…

BioMarin PharmaceuticalBiotechnologyNorth AmericaRare diseasesRegulationVimizim

Scottish regulator backs restricted NHS use of Janssen's Zytiga; negative on BioMarin's Firdapse

13-08-2012

The Scottish Medicines Consortium (SMC) announced yesterday that it has accepted Johnson & Johnson (NYSE:…

BioMarin PharmaceuticalEuropeFirdapseJanssenJohnson & JohnsonOncologyPharmaceuticalPricingRare diseasesRegulationZytiga

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