Regulation - Regulation, Dermatologicals

Filter

Current filters:

RegulationDermatologicals

Popular Filters

1 to 25 of 40 results

Novartis’ Cosentyx gets third approval, now in Europe

19-01-2015

The European Commission (EC) has approved Swiss pharma giant Novartis’ Cosentyx (secukinumab, formerly…

BiotechnologyCosentyxDermatologicalsEuropeNovartisRegulation

Celgene’s oral Otezla approved by EC for psoriasis and psoriatic arthritis

Celgene’s oral Otezla approved by EC for psoriasis and psoriatic arthritis

18-01-2015

US biotech firm Celgene’s European subsidiary has received marketing authorization from the European…

Anti-Arthritics/RheumaticsBiotechnologyCelgene CorpDermatologicalsEuropeOtezlaRegulation

Leo Pharma files for US approval of first aerosol foam for psoriasis

06-01-2015

Independent Danish dermatology specialist Leo Pharma has submitted a New Drug Application to the US Food…

BetamethasonecalcipotrienecalcipotriolDermatologicalsLEO PharmaPharmaceuticalRegulationUSA

First ever regulatory approval of Novartis' Cosentyx, in Japan

First ever regulatory approval of Novartis' Cosentyx, in Japan

26-12-2014

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Swiss pharma giant Novartis’…

Anti-Arthritics/RheumaticsBiotechnologyCosentyxDermatologicalsJapanNovartisRegulation

FDA approves Teva’s Granix and Galderma’s Soolantra

FDA approves Teva’s Granix and Galderma’s Soolantra

24-12-2014

The Food and Drug Administration has approved Israeli generics giant Teva Pharmaceutical Industries’…

DermatologicalsGaldermaGranixIvermectinPharmaceuticalRare diseasesRegulationSoolantraTeva Pharmaceutcal IndustriesUSA

Regeneron and Sanofi granted breakthrough designation for dupilumab

Regeneron and Sanofi granted breakthrough designation for dupilumab

25-11-2014

US biotech Regeneron Pharmaceuticals and French pharma major Sanofi have said that the US Food and Drug…

BiotechnologyDermatologicalsdupilumabRegeneronRegulationSanofiUSA

Novartis’ Cosentyx wins positive opinion from EMA’s CHMP

Novartis’ Cosentyx wins positive opinion from EMA’s CHMP

21-11-2014

Swiss pharma giant Novartis this morning revealed that the European Medicines Agency’s Committee for…

BiotechnologyCosentyxDermatologicalsEuropeNovartisRegulationsecukinumab

Sanofi and Regeneron’s dupilumab gets Breakthrough designation from FDA

20-11-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to French pharma major…

BiotechnologyDermatologicalsdupilumabRegeneronRegulationSanofiUSA

NICE seeks more information on Xolair to treat hives

19-11-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Swiss…

DermatologicalsNovartisPharmaceuticalPricingRegulationUKXolair

FDA panel unanimously backs Novartis’ secukinumab for moderate-to-severe plaque psoriasis

FDA panel unanimously backs Novartis’ secukinumab for moderate-to-severe plaque psoriasis

21-10-2014

The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration…

DermatologicalsNovartisPharmaceuticalRegulationsecukinumabUSA

Janssen files for EU approval of Stelara in pediatric plaque psoriasis

13-10-2014

Janssen-Cilag International says that a Type II Variation has been filed with the European Medicines…

BiotechnologyDermatologicalsEuropeInflammatory diseasesJanssen-CilagJohnson & JohnsonRegulationStelara

Celgene’s psoriasis drug Otezla gains FDA approval

Celgene’s psoriasis drug Otezla gains FDA approval

24-09-2014

The US Food and Drug Administration has approved biotech major Celgene’s Otezla (apremilast), an oral,…

BiotechnologyCelgene Corp.DermatologicalsOtezlaRegulationUSA

FTC puts conditions on Valeant’s acquisition of Precision Dermatology

FTC puts conditions on Valeant’s acquisition of Precision Dermatology

04-07-2014

Canada’s Valeant Pharmaceuticals International and its takeover target Precision Dermatology have agreed…

ActavisDermatologicalsMatawan PharmaceuticalsMergers & AcquisitionsPharmaceuticalPreCision DermatologyRegulationValeant Pharmaceuticals International

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

1 to 25 of 40 results

COMPANY SPOTLIGHT

Menarini

Back to top