Pharmaceutical - Pharmaceutical, North America, Women's Health

Retrophin to acquire Kyalin Biosciences; in-licenses Syntocinon


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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

GardasilMen's HealthMerck & CoNorth AmericaPharmaceuticalResearchVaccinesWomen's Health

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