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FDA backs Janssen’s Sylvant for rare disease


The US Food and Drug Administration yesterday approved Johnson & Johnson subsidiary Janssen Biotech’s…

Janssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRare diseasesRegulationsiltuximabSylvantUSA

Lilly's Cyramza first FDA-approved drug for advanced gastric cancer after prior chemo


The US Food and Drug Administration has approved pharma major Eli Lilly’s Cyramza (ramucirumab) as…

CyramzaEli LillyNorth AmericaOncologyPharmaceuticalRegulationUSA

AbbVie files NDA for oral, interferon-free treatment of hepatitis C


US drugmaker AbbVie has submitted its New Drug Application to the US Food and Drug Administration for…

AbbVieAnti-viralsEnanta PharmaceuticalsFinancialNorth AmericaPharmaceuticalRegulationUSA

US FDA clears pathway for Sarepta’s eteplirsen filing by year end


US RNA-based drug developer Sarepta Therapeutics it plans to submit a New Drug Application to the US…

BiotechnologyeteplirsenNorth AmericaRare diseasesRegulationSarepta TherapeuticsUSA

US Supreme Court denies Teva's request for injunction relating to Mylan’s generic Copaxone


The US Supreme Court Chief Justice Roberts has denied Israeli generics giant Teva Pharmaceutical Industries’…

CopaxoneGenericsLegalMylan LaboratoriesNeurologicalNorth AmericaPatentsTeva Pharmaceutical IndustriesUSA

FDA approves Merck’s Ragwitek for short ragweed pollen allergies


The US Food and Drug Administration has approved US pharma giant Merck & Co’s Biological License Application…

ALK AbelloImmunologicalsMerck & CoNorth AmericaPharmaceuticalRagwitekRegulationUSA

Teva and Pfizer settle patent litigation over Celebrex


Israel-based Teva Pharmaceutical Industries says that its US subsidiary has settled a law suit with US…

Anti-Arthritics/RheumaticsCelebrexGenericsNorth AmericaPatentsPfizerTeva Pharmaceutical IndustriesUSA

Astellas settles with US DoJ over Mycamine marketing

Astellas settles with US DoJ over Mycamine marketing


The US subsidiary of Japanese drug major Astellas Pharma will pay $7.3 million to resolve allegations…

Antibiotics and Infectious diseasesAstellas PharmaLegalMarkets & MarketingMycamineNorth AmericaPharmaceuticalUSA

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