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EMA consults on pharmacovigilance changes to medicines information


The European Medicines Agency has launched a public consultation on the changes to the product information…


FDA approves Truvada, first drug for reducing the risk of sexually acquired HIV infection


Despite protests from consumer groups such as the AIDS Healthcare Foundation (AHF), the US Food and Drug…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationTruvada

UK's NICE launches new medicines advisory service


The UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) last Friday launched…

Antibiotics and Infectious diseasesAstellas PharmaBiotechnologyDificlirEuropeGenericsPharmaceuticalRegulation

Merck & Co closes odanacatib trial early on good results in osteoporosis


US drug giant Merck & Co (NYSE: MRK) says it is halting a Phase III trial of its investigational osteoporosis…

Anti-Arthritics/RheumaticsMerck & CoodanacatibPharmaceuticalRegulationResearch

J&J'S rilpivirine also proven for combination HIV product, says IQWiG


Since the start of 2012, a new drug - rilpivirine from US health care giant Johnson & Johnson (NYSE:…

Anti-viralsEuropeEvipleraJohnson & JohnsonPharmaceuticalPricingRegulationrilpivirine

Arena Pharma files for Swiss approval of lorcaserin for weight control


USA-based Arena Pharmaceuticals (Nasdaq: ARNA) this week filed with the Swiss health authority, Swissmedic,…

Arena PharmaceuticalsEuropelorcaserinMetabolicsPharmaceuticalRegulation

GlaxoSmithKline readies for filing of diabetes drug albiglutide on positive final data


UK pharma giant GlaxoSmithKline (LSE: GSK) says that positive data from the Phase III Harmony 8 study…

albiglutideDiabetesGlaxoSmithKlineJanuviaMerck & CoPharmaceuticalRegulationResearch

Swissmedic clears Eisai's Inovelon for rare form of epilepsy


Japanese drug major Eisai's (TYO: 45230) European subsidiary says that the regulatory agency Swissmedic…


US patients get faster access to more cancer drugs than Europeans, says Tufts


Cancer patients in the USA get faster access to more oncology drugs to treat their disease than patients…

BiotechnologyEuropeHealthcareNorth AmericaOncologyPharmaceuticalPricingRegulation

Health Canada received nearly 42 thousand domestic AR reports in 2011


In 2011, the medical industry regulatory Health Canada received 41,923 domestic drug adverse reaction…

BiotechnologyHealthcareNorth AmericaPharmaceuticalRegulation

US FDA puts clinical hold on Ipsen and Inspiration's hemophilia drug candidate


There was bad news for French drugmaker Ipsen (Euronext: IPN) and partner privately-held US firm Inspiration…

IB1001Inspiration BiopharmaceuticalsIpsenNorth AmericaPharmaceuticalRegulationResearch

Human Genome resubmits raxibacumab BLA


US biotech firm Human Genome Sciences (Nasdaq: HGSI), the subject of a hostile takeover bid from GlaxoSmithKline,…

Antibiotics and Infectious diseasesBiotechnologyHuman Genome SciencesNorth AmericaraxibacumabRegulation

Australia's health care regulations struggle to keep up with population aging


The growing elderly population and its associated disease burden add to the economic challenges faced…

Asia-PacificHealthcareMarkets & MarketingPharmaceuticalPricingRegulation

US priority review for two Xarelto sNDAs; one dropped


The US Food and Drug Administration has assigned a priority review designation to the supplemental New…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

Sanofi pulls European and other regulatory filings for Mulsevo


The European Medicines Agency says it has been formally notified by French drug major Sanofi (Euronext:…

Cardio-vascularEuropeMulsevoNorth AmericaPharmaceuticalRegulationSanofisemuloparin

US FDA acts on safer use of ER and long-acting opioids


The US Food and Drug Administration yesterday approved a risk evaluation and mitigation strategy (REMS)…

NeurologicalNorth AmericaPharmaceuticalRegulation

Auxilium and Actelion get Xiaflex approval in Canada


US company Auxilium Pharmaceuticals (Nasdaq: AUXL) and the Canadian subsidiary of Actelion (SIX: ATLN),…

ActelionAuxilium PharmaceuticalsBiotechnologyNorth AmericaRare diseasesRegulationXiaflex

Regulatory filing preparations underway for Vifor's PA21 on good Ph III results


The pivotal Phase III clinical study shows that the new phosphate binder PA21 successfully controls hyperphosphatemia…

FreseniusGalenicaNephrology and HepatologyPA21PharmaceuticalRegulationResearchVifor Pharma

US FDA approves Erbitux as first-line treatment in KRAS wild-type EGFR


US drug majors Eli Lilly (NYSE: LLY) and Bristol-Myers Squibb (NYSE: BMY) on Friday received full approval…

Bristol-Myers SquibbEli LillyErbituxNorth AmericaOncologyPharmaceuticalQiagenRegulation

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