Regulation - Pharmaceutical, Dermatologicals

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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 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

Four medicines recommended for approval by EMA/CHMP

Four medicines recommended for approval by EMA/CHMP

22-12-2013

Following regular monthly meeting of the European Medicines Agency’s Committee for Medicinal Products…

AlconAntibiotics and Infectious diseasesComtriqDermatologicalsEuropeGaldermaJanssen-CilagJohnson & JohnsonMirvasoNovartisOncologyOphthalmicsPharmaceuticalRegulationSirturoTMC Pharma Services

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

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

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

LEO Pharma gets FDA nod for Picato

29-01-2012

Independent Danish drugmaker LEO Pharma says that the US Food and Drug Administration has approved its…

DermatologicalsLEO PharmaNorth AmericaPharmaceuticalPicatoRegulation

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