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Medicines Australia sets up new taskforce on transparency for payments to doctors


Medicines Australia has invited the Australian Medical Association, the Royal Australian College of Physicians,…

Asia-PacificFinancialMarkets & MarketingPharmaceuticalRegulationResearch

EMA explains EU incident management plan for human medicines


Earlier this week, the European Medicines Agency published the European Union regulatory network incident…


Shionogi partner Ildong gains South Korean approval for Pirespa


Japanese drug major Shionogi (TYO: 4507) says that its South Korean partner Ildong Pharma has received…

Asia-PacificIldong PharmaPharmaceuticalPirespapirfenidoneRegulationRespiratory and PulmonaryShionogi

US FDA accepts Teva's Quartette NDA


The US Food and Drug Administration has accepted for filing the New Drug Application for Quartette (levonorgestrel/ethinyl…

North AmericaPharmaceuticalQuartetteRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

Roche gains FDA approval for Lucentis in diabetic macular edema


US biotech firm Genentech, a subsidiary of Swiss drug major Roche (ROG: SIX) announced on Friday that…

GenentechLucentisNorth AmericaOphthalmicsPharmaceuticalRegulationRoche

New drug import licensing requirements for Ukraine passed by Parliament


A new law, introducing licensing on the imports of drugs to Ukraine and responsibility of foreign drug…

EuropeLegalMarkets & MarketingPharmaceuticalRegulation

US FDA approves Talon's rare leukemia drug Marqibo


California, USA-based Talon Therapeutics (OTCBB: TLON) yesterday gained accelerated approval from the…

MarqiboNorth AmericaOncologyPharmaceuticalRegulationTalon TherapeuticsTekmira Pharmaceuticals

UK's NICE delays decision on Roche's Zelboraf, asking for more information


UK health care watchdog the National Institute for Health and Clinical Excellence (NICE) today (August…


US health care reform looks to squeeze players up and down the value chain


This summer's landmark Supreme Court decision to uphold the USA's Patient Privacy and Affordable Care…

BiotechnologyFinancialHealthcareNorth AmericaPharmaceuticalRegulationResearch

EMA approves GlaxoSmithKline's Votrient for soft tissue sarcomas


UK pharma giant GlaxoSmithKline (LSE: GSK) says that the European Medicines Agency has approved Votrient…


World's first (official) biosimilar antibody goes to reumatoid arthritis


The end of July 2012 proved exciting for the world of biosimilar manufacturers. However, for the regulatory…

BiotechnologyCellTrionGenericsGlobalinfliximabJohnson & JohnsonMarkets & MarketingRegulationRemicadeRemsima

NICE rejects Alimera's Iluvien for DMO in draft guidance


In draft guidance published today (August 8) by UK drugs watchdog the National Institute for Health and…

Alimera SciencesEuropeIluvienOphthalmicsPharmaceuticalPricingRegulation

Pluristem cleared to start Phase I/II PLX cell study for muscle regeneration in Germany


In a second piece of good news this week, Israeli biotech company Pluristem Therapeutics (TASE: PLTR)…

BiotechnologyEuropePluristem TherapeuticsPLX cellsRegulationResearch

ViroPharma gets FDA backing for industrial scale Cinryze manufacturing


US biotech firm ViroPharma (Nasdaq: VPHM) says that the US Food and Drug Administration has approved…

BiotechnologyCinryzeNorth AmericaProductionRegulationReproductiveViroPharma

Links with academia changing way Pharma does science, says Tufts CSDD


Drug developers are forging new ways to work with academic medical centers to create the next generation…


GlaxoSmithKline files for EU and US approval for dabrafenib and trametinib


UK pharma giant GlaxoSmithKline (LSE: GSK) last week submitted regulatory filings in the European Union…

dabrafenibEuropeGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationtrametinib

UK NICE draft guidance backs Servier's Procoralan for chronic heart failure


The UK's drugs watchdog the National Institute for Health and Clinical Excellence (NICE), in draft guidance…


Zaltrap gains US approval for metastatic colorectal cancer


The US Food and Drug Administration on Friday approved French drug major Sanofi (Euronext: SAN) and US…

North AmericaOncologyPharmaceuticalRegeneronRegulationSanofiZaltrap

Positive outlook for Vectura, as Seebri Breezhaler closer to EU approval


UK-based inhalation product development company Vectura (LSE: VEC) is a step closer to European approval…

FinancialNovartisPharmaceuticalRegulationRespiratory and PulmonarySeebri BreezhalerVectura

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