Regulation - Regulation, Reproductive

Filter

Current filters:

RegulationReproductive

Popular Filters

1 to 25 of 39 results

Levonorgestrel and ulipristal remain suitable emergency contraceptives, says EMA

24-07-2014

The European Medicines Agency has concluded its review of emergency contraceptives containing levonorgestrel…

EuropeLevonorgestrelNorLevoPharmaceuticalRegulationReproductiveulipristalWomen's Health

EMA/CHMP positive opinion for Teva’s Seasonique contraceptive

EMA/CHMP positive opinion for Teva’s Seasonique contraceptive

04-07-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive…

EuropePharmaceuticalRegulationReproductiveSeasoniqueTeva Pharmaceutical IndustriesWomen's Health

Bayer gets “green light” for new transparent low dose contraceptive patch in the EU

Bayer gets “green light” for new transparent low dose contraceptive patch in the EU

14-02-2014

Germany’s Bayer says it has successfully concluded the decentralized European registration procedure…

BayerethinylestradiolEuropegestodenePharmaceuticalRegulationReproductive

FTC approves final order regarding Actavis’ acquisition of Warner Chilcott

FTC approves final order regarding Actavis’ acquisition of Warner Chilcott

12-12-2013

Following a public comment period, the US Federal Trade Commission has approved a final order settling…

ActavisGenericsMergers & AcquisitionsNorth AmericaRegulationReproductiveWarner Chilcott

Benefits of combined hormonal contraceptives continue to outweigh risks, says EMA/CHMP

Benefits of combined hormonal contraceptives continue to outweigh risks, says EMA/CHMP

23-11-2013

The European Medicines Agency has now completed its review of combined hormonal contraceptives (CHCs),…

EuropePharmaceuticalRegulationReproductiveWomen's Health

OvaScience slumps 38% on disappointing Augment update

11-09-2013

US fertility treatment specialist OvaScience (Nasdaq: OVAS) saw its shares plummet 38.4% to $8.80 in…

AugmentNorth AmericaOvaSciencePharmaceuticalRegulationReproductive

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

US FDA approval for Warner Chilcott's new oral contraceptive

26-07-2013

The US Food and Drug Administration have approved the use of a new oral contraceptive from Ireland-based…

ActavisLo Minastrin FeNorth AmericaPharmaceuticalRegulationReproductiveWarner Chilcott

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

FDA approves Plan B One-Step emergency contraceptive for OTC use by women of child-bearing potential

21-06-2013

The US Food and Drug Administration has approved the use of Plan B One-Step (levonorgestrel), from Israel-headquartered…

North AmericaPharmaceuticalPlan B One-StepRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

Actavis confirms patent challenge on Bayer's Safyral

06-06-2013

USA-based generics major Actavis (NYSE: ACT) yesterday (June 5) confirmed that it has filed an Abbreviated…

ActavisBayerGenericsPatentsRegulationReproductiveSafyralWomen's Health

FDA approves Raptor's Procysbi for rare genetic condition; and Plan B One-Step

01-05-2013

US drugmaker Raptor Pharmaceuticals (Nasdaq: RPTP) saw its share price rise 7.5% to $7.06 in mid-afternoon…

North AmericaPharmaceuticalPlan B One-StepProcysbiRaptor PharmaceuticalsRare diseasesRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

US FDA approves Teva's oral contraceptive Quartette

02-04-2013

There was good news for Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) when the US Food…

North AmericaPharmaceuticalQuartetteRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

EMA to review third- and fourth-generation combined OCs; France investigates Diane-35

29-01-2013

The European Medicines Agency has been asked by France to review third- and fourth-generation combined…

BayerDermatologicalsDiane-35EuropePharmaceuticalRegulationReproductiveWomen's Health

EMA Pharmacovigilance committee calls for Tredaptive suspension; contraceptives update

13-01-2013

At meetings held last week, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee…

Cardio-vascularEuropeMerck & CoNeurologicalPharmaceuticalRegulationReproductivetetrazepamTredaptive

Bayer's long-term contraceptive IUD Skyla gets US FDA approval

11-01-2013

The US Food and Drug Administration has approved German drug major Bayer's (BAYN: DE) Skyla (levonorgestrel-releasing…

BayerNorth AmericaPharmaceuticalRegulationReproductiveSkylaWomen's Health

Bayer expects EU launch of new long-term contraceptive system Jaydess in 2nd-qtr 2013

06-12-2012

German drug major Bayer (BAYN: DE) has successfully concluded the European Union registration procedure…

BayerEuropeJaydessLevonorgestrelMarkets & MarketingPharmaceuticalRegulationReproductive

Watson gets FDA final approval for generic Actos; negative news on Prochieve appeal

29-10-2012

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) said on Friday that it has launched a generic…

ActosDiabetesGenericsLegalMylan LaboratoriesNorth AmericaProchieveRegulationReproductiveTakeda PharmaceuticalsWatson Pharmaceuticals

Bayer's contraceptive Flexyess gets EC backing

10-10-2012

Bayer HealthCare, the drugs unit of Germany's Bayer AG (BAYN: DE), said yesterday that it has received…

BayerdrospirenoneethinylestradiolEuropeFlexyessPharmaceuticalRegulationReproductiveWomen's Health

Bayer files for EU approval of low-dose contraceptive patch

21-09-2012

German drug major Bayer (BAYN: DE) yesterday submitted an application for marketing authorization in…

BayerethinylestradiolEuropegestodenePharmaceuticalRegulationReproductiveWomen's Health

US FDA accepts Teva's Quartette NDA

13-08-2012

The US Food and Drug Administration has accepted for filing the New Drug Application for Quartette (levonorgestrel/ethinyl…

North AmericaPharmaceuticalQuartetteRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

1 to 25 of 39 results

Parexel

Parexel

Back to top