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SOBI granted marketing authorization for Xiapex in Peyronie's disease in the EU

SOBI granted marketing authorization for Xiapex in Peyronie's disease in the EU

02-02-2015

Nordic biotech firm Swedish Orphan Biovitrum (STO: SOBI) has received approval from the European Commission…

Men's HealthPharmaceuticalRegulationSobiXiaflexXiapex

Highlights from EMA Pharmacovigilance October meeting

10-10-2014

At its October meeting, the European Medicines Agency’ Pharmacovigilance Risk Assessment Committee…

Ariad PharmaceuticalsEuropeIclusigMen's HealthNeurologicalOncologyPharmaceuticalRegulationTestosteronevalproate

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

19-09-2014

The US Food and Drug Administration has approved a supplemental New Drug Application for Stendra (avanafil),…

Auxilium PharmaceuticalsMen's HealthPharmaceuticalRegulationStendraUSAVivus

FDA calls for tighter controls over testosterone replacement therapies

FDA calls for tighter controls over testosterone replacement therapies

19-09-2014

An advisory panel of the US Food and Drug Administration has voted to tighten use of testosterone replacement…

AndrogensAndrologyClarus TherapeuticsEndocrine systemMen's HealthPharmaceuticalRegulationRextoroTestosterone replacementUSA

FDA adding general warning to testosterone products potential for venous blood clots

FDA adding general warning to testosterone products potential for venous blood clots

22-06-2014

The US Food and Drug Administration is requiring manufacturers to include a general warning in the drug…

Men's HealthPharmaceuticalRegulationTestosteroneUSA

Pharmacovigilance Risk Assessment Committee April meeting highlights

Pharmacovigilance Risk Assessment Committee April meeting highlights

11-04-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation…

Cardio-vascularEuropeMen's HealthNeurologicalPharmaceuticalRegulationRespiratory and Pulmonary

Endo’s testosterone replacement Aveed gets FDA approval

Endo’s testosterone replacement Aveed gets FDA approval

06-03-2014

Endo International says its operating company Endo Pharmaceuticals has received US Food and Drug Administration…

AveedEndo PharmaceuticalsMen's HealthNorth AmericaPharmaceuticalRegulationUSA

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

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

03-02-2014

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

AbbVieActavisAndrodermAndroGelAxironEli LillyMen's HealthNorth AmericaPharmaceuticalRegulationResearchTestosteroneUSA

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