Pharmaceutical - Pharmaceutical, North America, Women's Health

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

Regulatory briefs: Gilead files sofosbuvir; FDA approves Diclegis; Health Canada clears Dysport

09-04-2013

US biotech firm Gilead Sciences (Nasdaq: GILD) says it has submitted a New Drug Application to the US…

Anti-viralsBiotechnologyDermatologicalsDiclegisDuchesnayDysportGilead SciencesIpsenNorth AmericaPharmaceuticalRegulationsofosbuvirValeant PharmaceuticalsWomen'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 news briefs: Biogen Idec's rFIXFc BLA accepted; 2nd CRL for Xarelto sNDA; negative vote on Depomed's Sefelsa and Hisamitsu's paroxetine mesylate

05-03-2013

US biotech firm Biogen Idec (Nasdaq: BIIB) says that the Food and Drug Administration has accepted the…

BayerBiogen IdecBiotechnologyCardio-vascularDepomedHisamitsu PharmaJohnson & JohnsonNorth Americaparoxetine mesylatePharmaceuticalRegulationrFIXFcSefelsaWomen's HealthXarelto

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

FDA accepts NDA filings from Pfizer/Ligand and Actelion; Bayer submits Alpharadin

16-12-2012

The US Food and Drug Administration accepted for review a New Drug Application from pharma behemoth Pfizer…

AlgetaAlpharadinBayerbazedoxifeneBiotechnologyConjugated EstrogensLigand PharmaceuticalsNorth AmericaOncologyOpsumitPfizerPharmaceuticalRegulationRespiratory and PulmonaryWomen'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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