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US FDA grants Valeant approval for Jublia NDA

US FDA grants Valeant approval for Jublia NDA

09-06-2014

Canadian drugmaker Valeant Pharmaceuticals International’s US subsidiary has received approval from…

CanadaDermatologicalsefinaconazoleJubliaPharmaceuticalRegulationUS Food and Drug AdministrationValeant Pharmaceuticals

NICE gives negative guidance on Janssen’s Stelara for psoriatic arthritis

NICE gives negative guidance on Janssen’s Stelara for psoriatic arthritis

28-05-2014

US health care giant Johnson & Johnson subsidiary Janssen today received a negative opinion from UK watchdog…

DermatologicalsInflammatory diseasesJanssenJohnson & JohnsonPharmaceuticalPricingRegulationStelaraUK

Pierre Fabre gains EU approval for Hemangiol, for proliferating infantile hemangioma

Pierre Fabre gains EU approval for Hemangiol, for proliferating infantile hemangioma

06-05-2014

French drugmaker Pierre Fabre Dermatologie Laboratories has obtained European Commission authorization…

DermatologicalsEuropeHemangeolHemangiolPharmaceuticalPierre FabreRegulation

FDA advisory unanimously recommends Durata’s Dalvance

FDA advisory unanimously recommends Durata’s Dalvance

01-04-2014

The US Food and Drug Anti-Infective Drugs Advisory Committee voted 12 to 0 that Durata Therapeutics’…

Antibiotics and Infectious diseasesDalvanceDermatologicalsDurata TherapeuticsNorth AmericaPharmaceuticalRegulationUSA

US FDA clears Xolair for chronic idiopathic urticaria

23-03-2014

Swiss drug major Novartis says the US Food and Drug Administration has approved Xolair (omalizumab) for…

BiotechnologyDermatologicalsGenentechNorth AmericaNovartisRegulationRocheUSAXolair

US FDA approves Pierre Fabre’s Hemangeol for infantile hemangioma

US FDA approves Pierre Fabre’s Hemangeol for infantile hemangioma

18-03-2014

Pierre Fabre Dermatologie has obtained marketing authorization from the US Food and Drug Administration…

DermatologicalsHemangeolNorth AmericaPharmaceuticalPierre FabreRegulationUSA

Allergan closes $65 million deal with Medytox

Allergan closes $65 million deal with Medytox

09-01-2014

This week US drugmaker Allergan (NYSE: AGN) announced that it has closed a $65 million license agreement…

AllerganAsia-PacificBotoxDermatologicalsLicensingMedytoxPharmaceuticalRegulationUKUSA

Rigel sees clear forward path for fostamatinib but will drop R333

25-10-2013

Clinical-stage US drug developer Rigel Pharmaceuticals has announced mixed updates on two of its pipeline…

BiotechnologyDermatologicalsfostamatinibImmunologicalsR333RegulationResearchRigel Pharmaceuticals

Galderma drug is first FDA-approved facial erythema of rosacea treatment

27-08-2013

Switzerland-headquartered Galderma Laboratories says that the US Food and Drug Administration has approved…

brimonidineDermatologicalsGaldermaMirvasoNorth AmericaPharmaceuticalRegulation

Actelion bid for Ceptaris looks secured as FDA approves Valchlor

26-08-2013

Privately-held USA-based Ceptaris Therapeutics revealed yesterday (August 26) that the US Food and Drug…

ActelionBiotechnologyCeptaris TherapeuticsDermatologicalsMergers & AcquisitionsNorth AmericaRegulationValchlor

EMA suspends use of oral ketoconazole because of liver injury risk

26-07-2013

The European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) has recommended…

DermatologicalsEuropeKetoconazolePharmaceuticalRegulation

Benefits of Diane 35 and generics outweigh risks in specific patient group, says EMA unit; other actions

17-05-2013

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that…

almitrineAnti-Arthritics/RheumaticsBayerDermatologicalsDiane-35EuropeOsseorPharmaceuticalProtelosRegulation

Briefs: Glenmark challenges Bayer patent; FDA delays Merck & Co's sugammadex

18-03-2013

Indian drugmaker Glenmark Generics confirms that it seeking US Food and Drug Administration approval…

BayerBridionDermatologicalsFinacea GelGenericsGlenmark PharmaceuticalsMerck & CoNeurologicalNorth AmericaPatentsPharmaceuticalRegulationsugammadex

Genentech Ph III study of omalizumab shows promise in CIU

25-02-2013

Genentech, the US biotech subsidiary of Swiss drug major Roche (ROG: SIX), announced results from a Phase…

BiotechnologyDermatologicalsGenentechNovartisOmalizumabPharmaceuticalRegulationResearchRespiratory and PulmonaryRocheXolair

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

Shire's Dermagraft cleared in Canada; settles Intuniv litigation

06-09-2012

Ireland headquartered Shire (LSE: SHP), NASDAQ: SHPG) says that its lead regenerative medicine product,…

Anchen PharmaceuticalsDermagraftDermatologicalsDiabetesGenericsIntunivNeurologicalNorth AmericaPatentsPharmaceuticalRegulationShireTWi Pharmaceuticals

Meda's Zyclara approved in the EU

29-08-2012

Sweden-based Meda (OMX: MEDA A) yesterday announced that the European Commission has granted marketing…

DermatologicalsEuropeMedaOncologyPharmaceuticalRegulationZyclara

Watson confirms patent challenges for Xopenox HFA and Epiduo Gel

31-07-2012

US generics drugmaker Watson Pharmaceuticals NYSE: WPI) has confirmed that its subsidiary, Watson Laboratories…

Dainippon Sumitomo PharmaDermatologicalsEpiduo GelGaldermaGenericsLegalNorth AmericaRegulationRespiratory and PulmonarySunovionWatson PharmaceuticalsXopenox

Janssen files NDA with FDA for canagliflozin in type 2 diabetes

01-06-2012

Janssen Research & Development, a subsidiary of health care giant Johnson & Johnson (NYSE: JNJ) has submitted…

canagliflozinDermatologicalsJanssenJohnson & JohnsonMitsubishi TanabeNorth AmericaPharmaceuticalRegulation

Ranbaxy gains US FDA approval for Absorica

29-05-2012

India's largest drugmaker Ranbaxy Laboratories (AB: BO) has received approval from the US Food and Drug…

AbsoricaCipher PharmaceuticalsDermatologicalsIsotretinoinNorth AmericaPharmaceuticalRanbaxy LaboratoriesRegulation

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