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US NDA filings for Vivus’ ED drug avanafil and Corcept’s Corlux for Cushing’s


California, USA-based Vivus (Nasdaq: VVUS) has submitted a New Drug Application has to the Food and Drug…

avanafilCorluxNorth AmericaPharmaceuticalRare diseasesRegulationReproductiveVivus

Doctors tell US FDA: “HIV prevention pill” - Gilead's Truvada - not ready for approval


Last week, a group of 55 US physicians sent a letter to the Food and Drug Administration urging the agency…

Anti-viralsGilead SciencesNorth AmericaPharmaceuticalRegulationTruvada

Bayer and Regeneron file for Japanese approval of wet AMD drug Eylea


Following swiftly on receiving a strong backing for the product from a US Food and Drug Administration…

Asia-PacificBayerEyleaOphthalmicsPharmaceuticalRegeneronRegulationVEGF Trap-Eye

Canadians waiting over two-and-a-half years for governments to approve new drugs


Canada’s federal and provincial government bureaucracies are taking more than two-and-a-half years…

HealthcareNorth AmericaPharmaceuticalRegulation

UK’s NICE sticks with negative view on Roche’s Tarceva for NSCLC


Having previously issued negative opinions on the cancer drug, this morning the UK’s National Institute…


US FDA accepts Pfizer NDA for kidney cancer drug axitinib


The US Food and Drug Administration has accepted global drugs behemoth Pfizer’s (NYSE: PFE) filing…

axitinibNorth AmericaOncologyPfizerPharmaceuticalRegulation

Amgen files Xgeva with FDA for additional indication


US biotech major Amgen (Nasdaq: AMGN) has submitted a supplemental Biologics License Application (sBLA)…

AmgenBiotechnologyNorth AmericaOncologyPharmaceuticalRegulationXgeva

Approvals for new pharma products in 2011 could exceed previous year, reports Fitch; Citeline says Ph IIIs up 13%


The pharmaceutical R&D pipeline for new pharmaceutical products remains strong for the remainder of 2011,…


US FDA again turns down approval of Pfizer and Pain Thera’s Remoxy


Pain Therapeutics (Nasdaq: PTIE) saw its shares plummet last Friday when, along with development partner…

NeurologicalNorth AmericaPain TherapeuticsPfizerPharmaceuticalRegulationRemoxy

Calls for wider data exclusivity reforms should not be supported in Australia, says GMiA


Most of the world’s population live with no more than six years or no data exclusivity at all, with…


US FDA modifies dosing for ESA’s Aranesp, Epogen and Procrit on cardiovascular risks


The US Food and Drug Administration on Friday recommended more conservative dosing guidelines for erythropoiesis-stimulating…

AmgenAranespBiotechnologyEpogenJohnson & JohnsonNorth AmericaOncologyPharmaceuticalProcritRegulation

Thumbs down from EMA for Amsterdam Molecular’s Glybera


Dutch human gene therapy firm Amsterdam Molecular Therapeutics (Euronext: AMT) says it has received a…

Amsterdam MolecularBiotechnologyEuropeGlyberaRare diseasesRegulation

Sanofi Pasteur gets WHO prequalification for Typhim Vi; opens R&D unit in Canada


Sanofi Pasteur, the vaccines division of French drug major Sanofi (Euronext: SAN) has been granted World…

FinancialPharmaceuticalRegulationResearchSanofiSanofi PasteurTyphimVaccines

CSL Biotherapies gets official warning letter from US FDA


The US Food and Drug Administration issued a formal warning letter to Australia’s largest biotech…

AfluriaAsia-PacificBiotechnologyCSL BiotherapiesCSL LimitedNorth AmericaRegulationVaccines

Merck KGaA drops plans for oral MS drug cladribine, leaving field clear for Gilenya


German drug major Merck KGaA (MRK: DE) said yesterday that, following feedback from regulatory authorities,…

CladribineGilenyaMarkets & MarketingMerck KGaANeurologicalNovartisPharmaceuticalRegulation

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