Regulation - GlaxoSmithKline, Rare diseases

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FDA backs added indication for GSK’s Promacta

FDA backs added indication for GSK’s Promacta

27-08-2014

The Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s supplemental New Drug…

GlaxoSmithKlineHematologyLigand PharmaceuticalsPharmaceuticalPromactaRare diseasesRegulationRevoladeUSA

GSK files for US approval for Promacta for severe aplastic anemia

GSK files for US approval for Promacta for severe aplastic anemia

02-03-2014

UK pharma giant GlaxoSmithKline has submitted a supplemental New Drug Application to the US Food and…

GlaxoSmithKlineLigand PharmaceuticalsNorth AmericaOncologyPharmaceuticalPromactaRare diseasesRegulationUSA

“Breakthrough Therapy” designation for GlaxoSmithKline’s Promacta/Revolade for SAA

“Breakthrough Therapy” designation for GlaxoSmithKline’s Promacta/Revolade for SAA

03-02-2014

The US Food and Drug Administration has granted “Breakthrough Therapy” designation for UK pharma…

GlaxoSmithKlinePharmaceuticalPromactaRare diseasesRegulationRevolade

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

FDA backs Baxter's Rixubis for hemophilia B; Breakthrough status for GSK's drisapersen

28-06-2013

The US Food and Drug Administration yesterday (June 27) approved Baxter International's (NYSE: BAX) Rixubis…

Baxter InternationaldrisapersenGlaxoSmithKlineNorth AmericaPharmaceuticalRare diseasesRegulationRixubis

Briefs: Roche deal with Chiasma; Vasella payout; FDA priority review for dolutegravir

18-02-2013

Swiss drug major Roche (ROG: SIX) has entered into an agreement to develop and commercialize privately…

Anti-viralsdolutegravirGlaxoSmithKlineLicensingManagementNovartisOctreotide AcetatePharmaceuticalRare diseasesRegulationRocheViiV Healthcare

US FDA approvals for Signifor, raxibacumab and Iclusig

17-12-2012

In a flurry of activity from the US Food and Drug Administration on Friday, the agency - which looks…

Antibiotics and Infectious diseasesAriad PharmaceuticalsGlaxoSmithKlineIclusigNorth AmericaNovartisOncologyPharmaceuticalRare diseasesraxibacumabRegulationSignifor

Isis Pharma/GlaxoSmithKline's ISIS-TTR Rx gains US fast-track designation

14-12-2012

In what has been a busy newsflow few days for USA-based Isis Pharmaceutical (Nasdaq: ISIS), the company…

BiotechnologyGlaxoSmithKlineIsis PharmaceuticalsISIS-TTR.RXLicensingNorth AmericaPharmaceuticalRare diseasesRegulation

UK NICE agrees to reconsider decision to deny NHS access to GSK's Benlysta

07-09-2012

The UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) confirmed this…

Anti-Arthritics/RheumaticsBenlystaEuropeGlaxoSmithKlinePharmaceuticalPricingRare diseasesRegulation

Germany's IQWiG finds in favor of Yervoy but not Benlysta or Fampyra

09-05-2012

The German Institute for Quality and Efficiency in Health Care (IQWiG) in the past few days issued a…

BenlystaBiogen IdecBiotechnologyBristol-Myers SquibbEuropeFampyraGlaxoSmithKlineNeurologicalOncologyPharmaceuticalPricingRare diseasesRegulationYervoy

UK NICE gives draft "No" to Benlysta, and negative final guidance for Tyverb and Herceptin

27-04-2012

There was a batch of bad news emanating from the US drugs watchdog the National Institute for Health…

Anti-Arthritics/RheumaticsBenlystaEuropeGlaxoSmithKlineHerceptinOncologyPharmaceuticalPricingRare diseasesRegulationRocheTyverb

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