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FDA investigating risk of stroke, heart attack and death with testosterone products

FDA investigating risk of stroke, heart attack and death with testosterone products


The US Food and Drug Administration said on Friday that it is investigating the risk of stroke, heart…

AbbVieActavisAndrodermAndroGelAxironEli LillyMen's HealthNorth AmericaPharmaceuticalRegulationResearchTestosteroneUSA

Patent settlements for Pfizer/Teva and Mylan/Eisai

Patent settlements for Pfizer/Teva and Mylan/Eisai


US pharma behemoth Pfizer says it has settled its long-standing litigation against a US subsidiary of…

Banner PharmacapsEisaiGenericsLegalMen's HealthMylan LaboratoriesNorth AmericaOncologyPatentsPfizerTargretinTeva Pharmaceutical IndustriesValeant PharmaceuticalsViagra

US FDA approves first drug treatment for Peyronie’s disease

US FDA approves first drug treatment for Peyronie’s disease


The US Food and Drug Administration has approved a new use for US company Auxilium Pharmaceuticals Xiaflex…

Auxilium PharmaceuticalsMen's HealthNorth AmericaPharmaceuticalRegulationXiaflex

Actavis confirms challenge of Lilly’s Axiron patent

Actavis confirms challenge of Lilly’s Axiron patent


US generics major Actavis confirms that it has filed an Abbreviated New Drug Application with the US…

ActavisAxironEli LillyGenericsLegalMen's HealthNorth AmericaPatentsRegulation

Auxilium gains rights to Vivus ED drug for USA and Canada


Auxilium Pharmaceuticals has signed an agreement with fellow USA-based Vivus providing Auxilium with…

Auxilium PharmaceuticalsLicensingMen's HealthNorth AmericaPharmaceuticalStendraVivus

US FDA delays action on Auxilium's Peyronie's sBLA


USA-based Auxilium Pharmaceuticals (Nasdaq: AUXL) says that the US Food and Drug Administration has notified…

Auxilium PharmaceuticalsMen's HealthNorth AmericaPharmaceuticalRegulationXiaflex

Generic launches by Mylan, Stada Arz and Dr Reddy's


US copy drugs maker Mylan (NYSE: MYL) has launched norethindrone tablets USP, 0.35 the generic version…

Dr Reddy's LaboratoriesEuropeGenericsLamictal XRMarkets & MarketingMen's HealthMicronorMylan LaboratoriesNeurologicalNorth AmericaReproductiveSTADA ArzneimittelViagra

Actavis and Kissei file law suits against Sandoz and Hetero over Rapaflo patent


USA-based Actavis (NYSE: ACT), itself predominantly a generic drug marketer, and Japan's Kissei Pharmaceutical…

ActavisGenericsHetero GroupMen's HealthNorth AmericaNovartisPatentsPharmaceuticalRapaflo CapsulesSandoz

Endo Pharma gets CTL from FDA relating to testosterone drug Aveed


response letter (CRL) regarding the New Drug Application (NDA) for subsidiary Endo Pharmaceuticals' long-acting…

AveedEndo Health SolutionsEndo PharmaceuticalsMen's HealthNorth AmericaPharmaceuticalRegulationTestosterone

Actavis wins generic Pulmicort Respules case; challenges AbbVie patent


US generic drugs maker Actavis (NYSE: ACT) has confirmed that the US District Court for the District…

AbbVieActavisAndroGelAstraZenecaGenericsMarkets & MarketingMen's HealthNorth AmericaPatentsPulmicort RespulesRegulationRespiratory and Pulmonary

Actavis confirms patent challenge to Endo's Fortesta


Generics drug giant Actavis (NYSE: ACT, formerly trading as Watson) has confirmed filing an Abbreviated…

ActavisEndo PharmaceuticalsFortestaGenericsMen's HealthNorth AmericaPatentsRegulation

Canada's Supreme Court paves way for generic Viagra


There was disappointing news for global pharma behemoth Pfizer (NYSE: PFE) yesterday, when the Canadian…

GenericsLegalMen's HealthNorth AmericaPatentsPfizerPharmaceuticalTeva Pharmaceutical IndustriesViagra

FTC seeks US Supreme Court review in AndroGel "pay-for-delay" case


At the request of the US Federal Trade Commission, the Solicitor General of the USA petitioned the country's…

Abbott LaboratoriesAndroGelGenericsLegalMen's HealthNorth AmericaPatentsPharmaceuticalSolvayWatson Pharmaceuticals

Amgen's Prolia gets FDA nod for men with osteoporosis


The US Food and Drug Administration last week approved a new indication for world biotech leader Amgen's…

AmgenAnti-Arthritics/RheumaticsBiotechnologyMen's HealthNorth AmericaProliaRegulation

Auxilium Pharma and GlaxoSmithKline to co-promote Testim in USA


US drugmaker Auxilium Pharmaceuticals (Nasdaq: AUXL) and the US subsidiary of UK pharma giant GlaxoSmithKline…

Auxilium PharmaceuticalsFinancialGlaxoSmithKlineMarkets & MarketingMen's HealthNorth AmericaPharmaceuticalTestim

US FDA clears new ED drug Stendra


The US Food and Drug Administration late Friday gave its approval for drug developer Vivus (Nasdaq: VVUS)…

avanafilMen's HealthNorth AmericaPharmaceuticalRegulationReproductiveStendraVivus

Gardasil does not trigger autoimmune conditions; study


US drug giant Merck & Co’s (NYSE: MRK) Gardasil ([human papillomavirus quadrivalent [types 6, 11,…

GardasilMen's HealthMerck & CoNorth AmericaPharmaceuticalResearchVaccinesWomen's Health

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Eleven Biotherapeutics

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