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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

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

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

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

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

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

ViroPharma gets FDA backing for industrial scale Cinryze manufacturing

07-08-2012

US biotech firm ViroPharma (Nasdaq: VPHM) says that the US Food and Drug Administration has approved…

BiotechnologyCinryzeNorth AmericaProductionRegulationReproductiveViroPharma

USA FDA approves ANDAs for Plan B One-Step and Trandate

16-07-2012

Watson Pharmaceuticals (NYSE: WPI) says its subsidiary Watson Laboratories approval from the US Food…

Cardio-vascularGenericsNorth AmericaPar PharmaceuticalsPlan B One-StepRegulationReproductiveTeva Pharmaceutical IndustriesTrandateWatson Pharmaceuticals

Warner Chilcott sues Watson over Lo Loestrin; Actavis debuts generic Requip

20-05-2012

Ireland-headquartered Warner Chilcott (Nasdaq: WCRX) has filed suit against USA-based Watson Pharmaceuticals…

ActavisGenericsGlaxoSmithKlineLegalLo LoestrinMarkets & MarketingNeurologicalNorth AmericaPatentsRegulationReproductiveRequip XLWarner ChilcottWatson Pharmaceuticals

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

Watson confirms patent challenge to Bayer’s Beyaz

13-02-2012

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) on Friday confirmed that its subsidiary, Watson…

BayerBeyazGenericsNorth AmericaPatentsRegulationReproductiveWatson Pharmaceuticals

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

FDA panel mixed on Ortho Evra

12-12-2011

The majority of members of the US Food and Drug Administration’s Reproductive Health Drugs Advisory…

Johnson & JohnsonNorth AmericaOrtho EvraPharmaceuticalRegulationReproductiveWomen's Health

Mixed views on drospirenone OCs

09-12-2011

The majority of members of the US Food and Drug Administration’s Reproductive Health Drugs Advisory…

BayerDrospirenone and EstradiolNorth AmericaPharmaceuticalRegulationReproductiveWomen's HealthYasminYaz

Mylan settles with Novartis over Vivelle-Dot; Impax files for generic Fentora

21-11-2011

US generics drugmaker Mylan (Nasdaq: MYL) says it has settled a patent litigation law suit with the US…

CephalonCIMA LabsFentoraGenericsImpax LaboratoriesMylan LaboratoriesNeurologicalNorth AmericaNovartisPatentsRegulationReproductiveVivelle-Dot

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