Pharmaceutical - Women's Health, North America

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Retrophin to acquire Kyalin Biosciences; in-licenses Syntocinon

13-12-2013

In a second takeover bid within a matter of months, USA-based Retrophin announced that it will acquire…

Kyalin BiosciencesLicensingMergers & AcquisitionsNeurologicalNorth AmericaNovartisPharmaceuticalRetrophinSyntocinonWomen's Health

FDA approves Bayer’s Adempas; firm accelerates drug candidates

FDA approves Bayer’s Adempas; firm accelerates drug candidates

09-10-2013

The US Food and Drug Administration late yesterday approved Adempas (riociguat), developed by German…

AdempasBayerCardio-vascularcopanlisibfinerenoneNorth AmericaOncologyPharmaceuticalRegulationResearchRespiratory and PulmonaryWomen's Health

US FDA backs Pfizer’s hot flashes drug Duavee

US FDA backs Pfizer’s hot flashes drug Duavee

04-10-2013

Pfizer and partner Ligand Pharmaceuticals say that the US Food and Drug Administration has approved Duavee,…

bazedoxifeneDuaveeLigand PharmaceuticalsNorth AmericaPfizerPharmaceuticalRegulationWomen's Health

Noven's Brisdelle is first non-hormonal treatment for menopausal hot flashes to be approved by FDA

01-07-2013

The US Food and Drug Administration on Friday (June 28) approved Noven Pharmaceuticals' Brisdelle (paroxetine)…

BrisdelleHisamitsu PharmaNorth AmericaNoven PharmaceuticalsparoxetinePharmaceuticalRegulationWomen's Health

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

FDA should not approve paroxetine or gabapentin for hot flashes, says Public Citizen

05-03-2013

A drug approved to treat depression and other mental health disorders and another designed to prevent…

DepomedgabapentinHisamitsu PharmaNorth AmericaparoxetinePharmaceuticalRegulationWomen's Health

FDA approves Shionogi's Osphena for postmenopausal women experiencing pain during sex

27-02-2013

The US Food and Drug Administration yesterday approved Japanese drug major Shionogi's (TYO: 4507) Osphena…

North AmericaospemifeneOsphenaPharmaceuticalQuatRx PharmaRegulationShionogiWomen's Health

Watson acquires Uteron Pharma; confirms Opana patent challenge

24-01-2013

US generic and specialty drugmaker Watson Pharmaceuticals (NYSE: WPI) says that it has completed the…

Endo PharmaceuticalsGenericsGrunenthalMergers & AcquisitionsNeurologicalNorth AmericaOpanaPatentsPharmaceuticalUteron PharmaWatson PharmaceuticalsWomen'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

Noven files NDA for non-hormonal therapy for menopausal vasomotor symptoms

30-08-2012

USA-based Noven Pharmaceuticals, a wholly-owned subsidiary of Japanese drugmaker Hisamitsu Pharmaceuticals…

Hisamitsu PharmaNorth AmericaNoven PharmaceuticalsPharmaceuticalRegulationWomen'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

Depomed to file NDA for Serada; with Valeant sues Watson over Glumetza

20-04-2012

US drugmaker Depomed (Nasdaq: DEPO) says that it has completed a Type B pre-New Drug Application meeting…

DepomedDiabetesGenericsGlumetzaNorth AmericaPatentsPharmaceuticalRegulationResearchSeradaValeant PharmaceuticalsWatson PharmaceuticalsWomen's Health

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

FDA approves Bayer HMB drug Natazia and EffRx osteo drug Binosto

15-03-2012

German drug major Bayer (BAY: DE) says its US subsidiary has received approval from the Food and Drug…

Anti-Arthritics/RheumaticsBayerBinostoEffRx PharmaceuticalsNataziaNorth AmericaPharmaceuticalRegulationWomen's Health

US FDA delays Eliquis decision; Pristiq dropped for menopause

02-03-2012

USA drug major Bristol-Myers Squibb (NYSE: BMY) and partner Pfizer (NYSE: PFE) say that the US Food and…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalPristiqRegulationWomen's Health

FDA OKs first quadrivalent flu vaccine; and lower dose Angeliq

01-03-2012

Anglo-Swedish drug major AstraZeneca (LSE: AZN) US unit MedImmune's FluMist Quadrivalent, a vaccine to…

Anti-viralsNorth AmericaPharmaceuticalRegulationVaccinesWomen's Health

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

Gardasil does not trigger autoimmune conditions; study

26-01-2012

US drug giant Merck & Co’s (NYSE: MRK) Gardasil ([human papillomavirus quadrivalent [types 6, 11,…

GardasilMen's HealthMerck & CoNorth AmericaPharmaceuticalResearchVaccinesWomen'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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