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Arzerra and ospemifene NDAs submitted in Japan


UK pharma giant GlaxoSmithKline (LSE: GSK) and Danish company Genmab A/S (OMX: GEN) have submitted a…

ArzerraAsia-PacificGenmabGlaxoSmithKlineOncologyospemifenePharmaceuticalQuatRx PharmaRegulationShionogiWomen's Health

Ukraine to introduce reference pricing and plans for prescription system


The Ukraine Ministry of Health and domestic producers of pharmaceuticals have signed a memorandum of…


US FDA delays Salix' Crofelemer approval


US drugmaker Salix Pharmaceuticals (Nasdaq: SLXP) revealed yesterday that the Food and Drug Administration…

crofelemerGastro-intestinalsNorth AmericaPharmaceuticalRegulationSalix Pharmaceuticals

Access to low-price generics threatened by technologies due to be used in EU


Producers of generic medicines are raising concerns on the huge cost implications of possible new anti-falsification…


Biopharmaceuticals "no longer a growth market" in Germany


After years of consistent growth, the German biopharmaceuticals market came to a juddering halt last…

BiotechnologyEuropeMarkets & MarketingPharmaceuticalPoliticsPricingRegulation

US FDA clears new ED drug Stendra


The US Food and Drug Administration late Friday gave its approval for drug developer Vivus (Nasdaq: VVUS)…

avanafilMen's HealthNorth AmericaPharmaceuticalRegulationReproductiveStendraVivus

FDA stalls Amgen's Xgeva sBLA for prevention of bone metastases


USA-based Amgen (Nasdaq: AMGN) revealed on Friday that the US Food and Drug Administration has issued…

AmgenBiotechnologyNorth AmericaOncologyRegulationXgeva

US FDA backs new indications for Votrient and Afinitor


The US Food and Drug Administration last week gave its approval for new indications for currently marketed…

AfinitorGlaxoSmithKlineNorth AmericaNovartisOncologyPharmaceuticalRegulationVotrient

US FDA again delays action on Takeda's alogliptin diabetes drug


Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) says it has received a complete response…

ActosalogliptinDiabetesNorth AmericaPharmaceuticalRegulationTakeda Pharmaceuticals

First Cushing's drug, Novartis' Signifor, approved in the EU


The European Commission has approved Swiss drug major Novartis' (NOVN: VX) Signifor (pasireotide) for…

EuropeNovartisOncologyPharmaceuticalRare diseasesRegulationSignifor

FDA extends review of Ironwood and Forest's linaclotide to September


The US Food and Drug Administration has told USA-based drugmakers Ironwood Pharmaceuticals (Nasdaq: IRWD)…

Forest LaboratoriesGastro-intestinalsIronwood PharmaceuticalslinaclotideNorth AmericaPharmaceuticalRegulation

Canada's drug review process needs enhancements, says diabetes charity


According to a new report by the charity the Canadian Diabetes Association, despite improvements to Canada's…

North AmericaPharmaceuticalRegulation

FDA strengthens monitoring of post-approval drug safety


In what is seen as a response to criticism that the agency lacks teeth in monitoring drugs once they…

BiotechnologyMarkets & MarketingNorth AmericaPharmaceuticalRegulation

Positive Ph III results for Novo Nordisk's degludec; US advocacy calls for Victoza's withdrawal


Danish diabetes specialist Novo Nordisk (NOV: N) says that its investigational ultra-long-acting insulin…

DegludecDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationResearchVictoza

Crucial need for global development of biosimilars, says head of European generics group


"The need for a framework which allows global biosimilars development is now crucial," argued European…


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