Regulation - GlaxoSmithKline, Roche

Filter

Current filters:

GlaxoSmithKlineRoche

Popular Filters

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

Regulatory updates on GSK's albiglutide, Roche's hep C test, Activartis AV0113

07-03-2013

UK pharma giant GlaxoSmithKline plc (LSE: GSK) says it has submitted a Marketing Authorization Application…

ActivartisalbiglutideAnti-viralsAV0113BiotechnologyDiabetesEperzanEuropeGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationRoche

GlaxoSmithKline pulls sNDA for Tykerb plus Herceptin; Watson/Actavis update

13-07-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) revealed yesterday that it has withdrawn a supplemental New…

ActavisGenericsGlaxoSmithKlineHerceptinMergers & AcquisitionsNorth AmericaOncologyPharmaceuticalRegulationRocheTykerbWatson Pharmaceuticals

Final guidance from UK NICE on Tarceva, Tyverb, Herceptin, Zytiga and Botox

26-06-2012

UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today published…

AllerganBotoxEuropeGlaxoSmithKlineHerceptinJanssenJohnson & JohnsonNeurologicalOncologyPharmaceuticalPricingRegulationRocheTarcevaTyverbZytiga

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

Roche to file for trastuzumab emtansine this year, on positive Ph III results

03-04-2012

Swiss drug major Roche (ROG: SIX) says that top-line results of EMILIA, the first randomized Phase III…

BiotechnologyGenentechGlaxoSmithKlineOncologyPharmaceuticalRegulationResearchRochetrastuzumab

EMA turns positive on orlistat and aprotinin; CHMP backs Pixuvri

20-02-2012

Finalizing its review on orlistat-containing medicines and the possible risk of severe liver injuries,…

AlliBayerBiotechnologyCardio-vascularCell TherapeuticsEuropeGlaxoSmithKlineMetabolicsOncologyorlistatPharmaceuticalPixuvriRegulationRocheTrasylolXenical

NICE views breast cancer drugs from GSK and Roche too expensive

14-02-2012

The UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has published draft…

EuropeGlaxoSmithKlineHerceptinOncologyPharmaceuticalPricingRegulationRocheTyverb

Back to top