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French government delists certain Ipsen products


French drugmaker Ipsen (Euronext: IPN) announced the French government’s decision to no longer reimburse…

EuropeGingko bilobaIpsenMarkets & MarketingNeurologicalPharmaceuticalRegulation

Department of Justice seeks permanent injunction against Ranbaxy


The US Department of Justice, on behalf of the Food and Drug Administration, has filed a consent decree…

Asia-PacificGenericsLegalNorth AmericaRanbaxy LaboratoriesRegulation

Overview of biologic regulations in India


Currently, all biologics in India, including innovative and copy biologics are approved as new drugs,…


US FDA mixed views on Vytorin and Zetia


US drug giant Merck & Co (NYSE: MRK) yesterday received Food and Drug Administration approval to update…

Cardio-vascularMerck & CoNephrology and HepatologyNorth AmericaPharmaceuticalRegulationVytorinZetia

Expanded use for Merck Serono’s Rebif in EU


Merck Serono, the Switzerland-based division of Germany’s Merck KGaA (MRK: DE), says that that the…

EuropeMerck KGaAMerck SeronoNeurologicalPharmaceuticalRebifRegulation

Some advantages seen for Sanofi’s Jevtana by Germany’s IQWiG


In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG)…


Genzyme Framingham plant now cleared by US and EU regulators


French drug major Sanofi (Euronext: SAN) said yesterday that the US Food and Drug Administration has…

BiotechnologyFabrazymeGenzymePharmaceuticalRare diseasesRegulationSanofi

Germany’s IQWiG sees added benefits for Incivo


In an early benefit assessment pursuant to Germany’s Act on the Reform of the Market for Medicinal…

Anti-viralsEuropeIncivekIncivoJanssenJohnson & JohnsonPharmaceuticalPricingRegulationVertex

FDA lifts hold on Insmed Arikace trial


USA-based biopharma company Insmed’s (Nasdaq CM: INSM) shares leapt 33.7% to $5.08 on Friday, after…

ArikaceBiotechnologyInsmedNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonary

EMA starts review of Gilenya; guidance on biosimilar interferon beta


The European Medicines Agency has begun a review of the benefits and risks of Swiss drug major Novartis’…

BiotechnologyEuropeGenericsGilenyainterferon betaNeurologicalNovartisPharmaceuticalRegulation

FDA updates Tysabri label relating to anti-JCV


The US Food and Drug Administration on Friday approved a product label change for Tysabri (natalizumab),…

Biogen IdecBiotechnologyElanNeurologicalNorth AmericaPharmaceuticalRegulationTysabri

EMA panel backs Novartis Cushing’s disease drug; Glivec label change


The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended…

EuropeGlivecNovartisOncologypasireotidePharmaceuticalRare diseasesRegulationSignifor

FDA Advisory thumbs down for Columbia and Watson product


US drugmakers Columbia Laboratories (Nasdaq: CBRX) and Watson Pharmaceuticals (NYSE: WPI) confirmed on…

Columbia LaboratoriesCrinoneNorth AmericaPharmaceuticalRegulationReproductiveWatson PharmaceuticalsWomen's Health

Merck & Co gets positive CHMP opinion for Remicade in new indication


US drug giant Merck & Co (NYSE: MRK) says that announced that the European Medicines Agency’s Committee…

EuropeGastro-intestinalsMerck & CoPharmaceuticalRegulationRemicade

Additional indication for Otsuka’s Abilify in Japan


Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) said last week that it has received new regulatory…


Eisai gets Lunesta approval in Japan, launches Fostoin


Japanese drug major Eisai (TYO: 4523) this week received approval from Japan's Ministry of Health, Labor…

Asia-PacificEisaiFostoinLunestaMarkets & MarketingNeurologicalNobelpharmaPharmaceuticalRegulation

FDA backs Gilead’s Viread for children


The US Food and Drug Administration has approved US biotech firm Gilead Sciences (Nasdaq: GILD) Viread…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationViread

Which of 2012's launches will be future blockbusters?


A review of the year's biggest product launches - based on analyst forecasts - reveals a bumper crop…


FDA’s CRL on dapagliflozin calls for more clinical data


In what comes as no surprise given a negative vote by an Food and Drug Administration advisory panel…

AstraZenecaBristol-Myers SquibbdapagliflozinDiabetesNorth AmericaPharmaceuticalRegulation

Bayer’s Xarelto OKed in Japan; promising regorafenib data


Bayer Healthcare, a unit of Germany’s Bayer AG (BAY: DE), had a couple of good news item to report…

BayerCardio-vascularOncologyOnyx PharmaceuticalsPharmaceuticalregorafenibRegulationResearchXarelto

2307 to 2331 of 2588 results

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