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FDA backs Novartis' Afinitor for advanced breast cancer


There was good news for Swiss drug major Novartis (NOVN: VX) on Friday, when the US Food and Drug Administration…

AfinitorNorth AmericaNovartisOncologyPharmaceuticalRegulation

EMA unit recommends limiting long-term use of calcitonin medicines


The European Medicines Agency said on Friday that its Committee for Medicinal Products for Human Use…


EMA accepts Pfizer's bazedoxifene/CE marketing application


The European Medicines Agency has accepted for review drug behemoth Pfizer's (NYSE: PFE) Marketing Authorization…

Anti-Arthritics/RheumaticsbazedoxifeneEuropePfizerPharmaceuticalRegulationWomen's Health

Alimera's Iluvien approved in France for diabetic macular edema


USA-based ophthalmic biopharma specialist Alimera Sciences (Nasdaq: ALIM) says that French regulator…

Alimera SciencesEuropeFinancialIluvienOphthalmicsPharmaceuticalRegulation

Lithuania and Poland negotiate joint drug packaging agreement


In a high level meeting, government officials from Lithuania and Poland explored the possibility to legalize…


FDA further delays Novo Nordisk's ultra long-acting insulin products Tresiba and Ryzodeg


Denmark's Novo Nordisk (NOV: N), the world's largest insulin maker, says that the US Food and Drug Administration…

DiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationRyzodegTresiba

EU Commission proposes to revamp rules on clinical trials to make Europe more attractive for research


With the aim of boosting clinical research in Europe by simplifying the rules for conducting clinical…


US FDA approves second diet pill, Vivus' Qsymia


In a much anticipated but largely expected decision, the US Food and Drug Administration yesterday approved…

MetabolicsNorth AmericaPharmaceuticalQnexaQsymiaRegulationVivus

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

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