Pharmaceutical - Women's Health, Regulation

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Highlights of EMA Pharmacovigilance committee July meeting

Highlights of EMA Pharmacovigilance committee July meeting

14-07-2014

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) concluded two safety…

bromocriptineEuropeNephrology and HepatologyNeurologicalPharmaceuticalRegulationRiensoTakeda Pharmaceuticalvalproate Sodium InjectionWomen'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

US orphan status for EffRx’ EX404 for pediatric polycystic ovary syndrome

US orphan status for EffRx’ EX404 for pediatric polycystic ovary syndrome

11-06-2014

Swiss drug delivery specialist EffRx Pharmaceuticals says the US Food and Drug Administration has granted…

EffRx PharmaceuticalsEX404metforminPharmaceuticalRare diseasesRegulationUSAWomen's Health

GPs lack awareness of NICE guidelines on HMB, survey shows

GPs lack awareness of NICE guidelines on HMB, survey shows

09-05-2014

Less than 5% of UK general practitioners (GPs) prescribe in line with guidelines from the National Institute…

BayerHealth Medical PharmaHealth Medical PharmaMilitary scienceNavigationPharmaceuticalRegulationSocial IssuesUKWomen's Health

GSK withdraws European marketing authorization for ovarian cancer drug Votrient

GSK withdraws European marketing authorization for ovarian cancer drug Votrient

31-03-2014

UK pharma major GlaxoSmithKline has withdrawn its application to the European Medicines Agency for a…

GlaxoSmithKlineOncologyPharmaceuticalRegulationUKVotrientWomen's Health

US FDA approves NDA from Actavis and Valeant

US FDA approves NDA from Actavis and Valeant

26-03-2014

US generics major Actavis and Canada’s Valeant Pharmaceuticals said that the US Food and Drug Administration…

ActavisCanadaGenericsMetronidazolePharmaceuticalRegulationUSAValeant PharmaceuticalsWomen's Health

Sprout Pharmaceuticals to resubmit NDA for flibanserin

Sprout Pharmaceuticals to resubmit NDA for flibanserin

12-02-2014

US privately-held sexual health specialists Sprout Pharmaceuticals has received ‘clear guidance’…

flibanserinPharmaceuticalRegulationSprout PharmaceuticalsUSAWomen's Health

European Commission approves Gedeon Richter’s Esmya type II Variation

European Commission approves Gedeon Richter’s Esmya type II Variation

27-01-2014

The European Commission has granted marketing authorization to extend the use of Esmya (ulipristal acetate)…

EsmyaEuropeGedeon RichterPharmaceuticalRegulationWomen's Health

EMA pharmacovigilance unit calls for suspension of Protelos/Osseor

EMA pharmacovigilance unit calls for suspension of Protelos/Osseor

10-01-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended…

Anti-Arthritics/RheumaticsEuropeOsseorPharmaceuticalProtelosRegulationServierWomen's Health

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

Contraceptive benefits outweigh risks of blood clots, say EMA

Contraceptive benefits outweigh risks of blood clots, say EMA

14-10-2013

The European Medical Agency’s Pharmacovigilance Risk Assessment Committee has decided that the benefits…

EuropePharmaceuticalRegulationWomen'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

Pharmacovigilance Risk Assessment Committee meeting highlights

06-09-2013

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) gave recommendations…

bromocriptineEuropeNumetaPharmaceuticalRegulationWomen'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

Japan vaccines briefs: Gardasil and Cervarix; Daiichi Sankyo files NDA

21-06-2013

The Japanese Ministry of Health, Labor and Welfare has decided to withdraw its recommendation for a vaccination…

Asia-PacificCervarixDaiichi SankyoGardasilGlaxoSmithKlineMerck & CoPharmaceuticalRegulationVaccinesWomen'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

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

1 to 25 of 43 results

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