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

01-07-2011

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

01-07-2011

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

30-06-2011

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

29-06-2011

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

29-06-2011

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

EuropeOncologyPharmaceuticalPricingRegulationRocheTarceva

US FDA accepts Pfizer NDA for kidney cancer drug axitinib

29-06-2011

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

29-06-2011

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%

28-06-2011

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

BiotechnologyPharmaceuticalRegulationResearch

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

28-06-2011

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

28-06-2011

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

Asia-PacificGenericsPatentsPharmaceuticalRegulation

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

27-06-2011

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

27-06-2011

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

24-06-2011

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

23-06-2011

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

23-06-2011

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

CladribineGilenyaMarkets & MarketingMerck KGaANeurologicalNovartisPharmaceuticalRegulation

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