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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

US FDA approves first drug treatment for Peyronie’s disease

US FDA approves first drug treatment for Peyronie’s disease

07-12-2013

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

14-11-2013

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

ActavisAxironEli LillyGenericsLegalMen's HealthNorth AmericaPatentsRegulation

Apricus ED drug gains national phase approval in Germany

09-10-2013

Germany's Federal Institute for Drugs and Medical Devices has granted national phase approval for USA-based…

Apricus BioscienceEuropeMen's HealthPharmaceuticalRegulationSandozVitaros

Swiss regulator stalls approval of Apricus Biosciences' Vitaros

02-09-2013

USA-based Apricus Biosciences (Nasdaq: APRI) says that Swissmedic, the Agency for Therapeutic Products…

Apricus BioscienceEuropeMen's HealthPharmaceuticalRegulationVitaros

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

28-08-2013

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

Auxilium PharmaceuticalsMen's HealthNorth AmericaPharmaceuticalRegulationXiaflex

Apricus Biosciences gains two more approvals for ED drug Vitaros

15-08-2013

USA-based Apricus Biosciences (Nasdaq: APRI) says that the Irish Medicines Board and the Netherlands'…

Apricus BioscienceEuropeMen's HealthPharmaceuticalRegulationReproductiveVitaros

European approval for Vivus' ED drug Spedra

27-06-2013

The European Commission yesterday (June 26) has granted marketing authorization for USA-based Vivus'…

avanafilEuropeMen's HealthPharmaceuticalRegulationReproductiveSpedraVivus

Endo Pharma gets CTL from FDA relating to testosterone drug Aveed

31-05-2013

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

02-04-2013

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

04-03-2013

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

ActavisEndo PharmaceuticalsFortestaGenericsMen's HealthNorth AmericaPatentsRegulation

Study finds "Big Pharma" fails at self-policing ED drug advertising

18-02-2013

The pharmaceutical industry's efforts to self-regulate its direct-to-consumer (DTC) advertising are "an…

BayerCialisEli LillyLevitraMarkets & MarketingMen's HealthPfizerPharmaceuticalRegulationViagra

European Commission approves Lilly's Cialis for BPH

31-10-2012

The European Commission has approved US drug major Eli Lilly's (NYSE: LLY) Cialis (tadalafil), 5mg for…

CialisEli LillyEuropeMen's HealthPharmaceuticalRegulation

Amgen's Prolia gets FDA nod for men with osteoporosis

24-09-2012

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

AmgenAnti-Arthritics/RheumaticsBiotechnologyMen's HealthNorth AmericaProliaRegulation

US FDA clears new ED drug Stendra

30-04-2012

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

avanafilMen's HealthNorth AmericaPharmaceuticalRegulationReproductiveStendraVivus

Astellas files for EU approval of EC905, EMA accepts avanafil filing

28-03-2012

The European subsidiary of Japanese drug major Astellas Pharma (Tokyo: 4503) has announced the submission…

Astellas PharmaavanafilEuropeMen's HealthPharmaceuticalRegulationVivus

Fake erectile dysfunction drugs seized in joint international raids

21-03-2012

In a joint operation, known as Operation Tribulus, led by Spanish police and coordinated by Europol,…

CialisEuropeLevitraMarkets & MarketingMen's HealthPharmaceuticalRegulationViagra

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