Regulation - Reproductive, Pharmaceutical

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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

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

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

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

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

Bayer's Xarelto reimbursement backed in Canada; EMA concludes Yvidually arbitration

24-04-2012

The Canadian Agency for Drugs and Technologies in Health (CADTH) through the Common Drug Review (CDR),…

BayerCardio-vascularEuropeNorth AmericaPharmaceuticalPricingRegulationReproductiveXareltoYvidually

Bayer updates drospirenone-containing COCs labels to reflect VTE risk

11-04-2012

Following a further review of the products by the US Food and Drug Administration , Bayer HealthCare…

BayerBeyazdrospirenoneNorth AmericaPharmaceuticalRegulationReproductiveWomen's HealthYasminYaz

Columbia Labs hands over NDA to Watson

13-02-2012

Columbia Laboratories (Nasdaq: CBRX) has transferred the New Drug Application for progesterone vaginal…

Columbia LaboratoriesCrinoneLicensingNorth AmericaPharmaceuticalRegulationReproductiveWatson PharmaceuticalsWomen's Health

FDA Advisory thumbs down for Columbia and Watson product

23-01-2012

US drugmakers Columbia Laboratories (Nasdaq: CBRX) and Watson Pharmaceuticals (NYSE: WPI) confirmed on…

Columbia LaboratoriesCrinoneNorth AmericaPharmaceuticalRegulationReproductiveWatson PharmaceuticalsWomen's Health

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