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GlaxoSmithKline files for EU and US approval for dabrafenib and trametinib


UK pharma giant GlaxoSmithKline (LSE: GSK) last week submitted regulatory filings in the European Union…

dabrafenibEuropeGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationtrametinib

UK NICE draft guidance backs Servier's Procoralan for chronic heart failure


The UK's drugs watchdog the National Institute for Health and Clinical Excellence (NICE), in draft guidance…


Zaltrap gains US approval for metastatic colorectal cancer


The US Food and Drug Administration on Friday approved French drug major Sanofi (Euronext: SAN) and US…

North AmericaOncologyPharmaceuticalRegeneronRegulationSanofiZaltrap

Positive outlook for Vectura, as Seebri Breezhaler closer to EU approval


UK-based inhalation product development company Vectura (LSE: VEC) is a step closer to European approval…

FinancialNovartisPharmaceuticalRegulationRespiratory and PulmonarySeebri BreezhalerVectura

European Medicines Agency phasing out follow-up measures for MAs


The European Medicines Agency this week issued a statement reminding marketing-authorization holders…


USA's PDUFA V begins with relatively modest changes to user fee rates


In two Federal Register notices published on August 1, the US Food and Drug Administration announced…

BiotechnologyFinancialNorth AmericaPharmaceuticalRegulation

US FDA rejects Regeneron's Arcalyst sBLA for gout flare prevention


US drugmaker Regeneron Pharmaceuticals (Nasdaq: REGN) says that the US Food and Drug Administration issued…

Anti-Arthritics/RheumaticsArcalystBiotechnologyNorth AmericaPharmaceuticalRegeneronRegulation

Positive new data for Pfizer's tofacitinib; possible regulatory delay


Pfizer (NYSE:PFE), the world's largest drugmaker by sales, yesterday released positive top-line results…

Anti-Arthritics/RheumaticsNorth AmericaPfizerPharmaceuticalRegulationResearchtofacitinib

EMA increases interaction with Japanese regulators


The European Medicines Agency has increased its level of interaction and cooperation with medicines regulatory…

Asia-PacificBiotechnologyEuropePharmaceuticalRare diseasesRegulation

EU approval for Eisai's epilepsy drug Fycompa and Vertex' Kalydeco


Japanese drug major Eisai (TYO: 4523) says that the European Commission has approved for marketing its…

EisaiEuropeFycompaKalydecoNeurologicalPharmaceuticalRare diseasesRegulationVertex

Genentech gains FDA panel backing for Lucentis to treat DME


US biotech firm Genentech, a subsidiary of Swiss drug major Roche (ROG: SIX), revealed last week that…

BiotechnologyGenentechLucentisNorth AmericaOphthalmicsPharmaceuticalRegulationRoche

US FDA clears Amarin's Vascepa, a competitor for Lovaza


The US Food and Drug Administration has approved biotech firm Amarin's (Nasdaq: AMRN) Vascepa (icosapent…

AmarinBiotechnologyCardio-vascularGlaxoSmithKlineLovazaMergers & AcquisitionsNorth AmericaRegulationVascepa

FDA advisory panel backs approval of ThromboGenics' ocriplasmin for VMA


Belgian biopharmaceutical firm ThromboGenics NV (Euronext Brussels: THR) says that the US Food and Drug…

AlconBiotechnologyNorth AmericaNovartisocriplasminOphthalmicsRegulationThromboGenics

US doctors, researchers and health officials want FDA action to deter mis-prescribing of opioid painkillers


Labels on opioid pain medications should be revised to prevent overprescribing, a broad coalition of…

NeurologicalNorth AmericaPharmaceuticalRegulation

Global pharmaceutical approvals moderate as patent cliff peaks, says Fitch


The Food and Drug Administration will approve fewer novel drugs in 2012 compared to 2011 while the industry…

BiotechnologyNorth AmericaPatentsPharmaceuticalRegulation

Boehringer and Lilly's combo diabetes drug Jentadueto gains EU approval


Independent German drug major Boehringer Ingelheim and US partner Eli Lilly (NYSE: LLY) received Marketing…

Boehringer IngelheimDiabetesEli LillyEuropeJentaduetoPharmaceuticalRegulation

US FDA points to seizure risk with Acorda's MS drug Ampyra


The US Food and Drug Administration has issued a warning about the risk of seizures in patients with…

Acorda TherapeuticsAmpyraNeurologicalNorth AmericaPharmaceuticalRegulation

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