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US FDA approves new antibacterial drug Avycaz

US FDA approves new antibacterial drug Avycaz

26-02-2015

The US Food and Drug Administration has approved antibacterial drug Avycaz (ceftazidime-avibactam) to…

ActavisAntibiotics and Infectious diseasesceftazidime-avibactamForest PharmaceuticalsPharmaceuticalRegulationUSA

Biosimilars viable only for biologics with sales of $898 million, says Prime Therapeutics report

Biosimilars viable only for biologics with sales of $898 million, says Prime Therapeutics report

26-02-2015

Although there is widespread optimism around the first biosimilars being launched in the USA, a new report…

BiosimilarsProductionRegulationUnited StatesUSA

Actavis confirms generic Uceris patent challenge

Actavis confirms generic Uceris patent challenge

25-02-2015

Ireland-headquartered generics major Actavis yesterday confirmed that it has filed an Abbreviated New…

ActavisCosmo TechnologiesGastro-intestinalsGenericsPatentsRegulationSalix PharmaceuticalsSantarusUcerisUSAValeant Pharmaceuticals International

Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

24-02-2015

The US Federal Trade Commission has put conditions on the proposed acquisition by Novartis of GlaxoSmithKline’s…

Array BioPharmaGSKLegalMergers & AcquisitionsNovartisOncologyPharmaceuticalRegulationResearchUSA

US FDA approves Novartis’ Farydak, the first HDAC inhibitor for MM patients

24-02-2015

The US Food and Drug Administration yesterday approved Swiss pharma giant Novartis’ Farydak (panobinostat,…

FarydakNovartisOncologypanobinostatPharmaceuticalRegulationUSA

Eli Lilly delays US and Europe filings for new diabetes agent peglispro

23-02-2015

US pharma major Eli Lilly says it is delaying the submission of its basal insulin peglispro (BIL) to…

DiabetesEli LillyEuropepeglisproPharmaceuticalRegulationUSA

FDA accepts for review Synageva's Biologics License Application for Kanuma

FDA accepts for review Synageva's Biologics License Application for Kanuma

23-02-2015

The US Food and Drug Administration has accepted for review the Biologics License Application for Kanuma…

BiotechnologyGeneticsKanumaRegulationSynageva BioPharmaUSA

Actavis receives final FDA approval for generic version of Subutex

Actavis receives final FDA approval for generic version of Subutex

22-02-2015

Ireland-headquartered generics major Actavis has received final approval from the US Food and Drug Administration…

Abbreviated New Drug ApplicationGenericsIndiviorNeurologicalRC PharmaceuticalsReckitt BenckiserRegulationSubutexUSA

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