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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

Janssen pulls EU application for IV Simponi

19-05-2014

Janssen Biologics, a European subsidiary of US health care giant Johnson & Johnson, says it has withdrawn…

Anti-Arthritics/RheumaticsBiotechnologyEuropeJanssenJohnson & JohnsonRegulationSimponi Injection

UK’s NICE backs Janssen’s Invokana for type 2 diabetes

16-05-2014

Janssen, a subsidiary of US health care giant Johnson & Johnson, said today that it welcomes the publication…

DiabetesInvokanaJanssenJohnson & JohnsonPharmaceuticalPricingRegulationUK

Negative NICE draft guidance on Janssen’s Zytiga for prostate cancer

Negative NICE draft guidance on Janssen’s Zytiga for prostate cancer

14-05-2014

In draft guidance published this morning, the UK drugs watchdog the National Institute for Health and…

JanssenJohnson & JohnsonOncologyPharmaceuticalPricingRegulationUKZytiga

Janssen submits sNDA for Olysio in combination with sofosbuvir

Janssen submits sNDA for Olysio in combination with sofosbuvir

08-05-2014

Janssen Research & Development, a subsidiary of US health care giant Johnson & Johnson, has submitted…

Anti-viralsBiotechnologyGilead SciencesJanssenJohnson & JohnsonOlysioRegulationSovaldiUSA

Once-monthly Invega Sustenna reduces risk of relapse in schizoaffetive disorder

Once-monthly Invega Sustenna reduces risk of relapse in schizoaffetive disorder

07-05-2014

US health care giant Johnson & Johnson subsidiary Janssen Pharmaceuticals has released positive results…

Invega SustennaJanssenJohnson & JohnsonNeurologicalPharmaceuticalRegulationResearch

Topamax safety concerns as a treatment for migraines in adolescents, despite recent FDA approval

Topamax safety concerns as a treatment for migraines in adolescents, despite recent FDA approval

11-04-2014

The US Food and Drug Administration’s recent approval of Johnson & Johnson subsidiary Janssen’s Topamax…

JanssenJohnson & JohnsonMarkets & MarketingNeurologicalPharmaceuticalRegulationTopamax

UK’s NICE does not recommend Janssen’s Stelara for psoriatic arthritis

UK’s NICE does not recommend Janssen’s Stelara for psoriatic arthritis

28-03-2014

Final draft guidance from the UK health care costs watchdog the National Institute for Health and Care…

Anti-Arthritics/RheumaticsJanssenJohnson & JohnsonNorthern EuropePharmaceuticalPricingRegulationStelara InjectionUK

Positive CHMP opinion for Janssen’s simeprevir for chronic hepatitis C

24-03-2014

US health care giant Johnson & Johnson’s European subsidiary Janssen R&D Ireland has received a positive…

Anti-viralsEuropeJanssenJohnson & JohnsonMedivirOlysioPharmaceuticalRegulationsimeprevir

UK NICE backs Janssen’s Velcade for multiple myeloma

UK NICE backs Janssen’s Velcade for multiple myeloma

21-03-2014

In new draft guidance published today, UK drugs watchdog the National Institute for Health and Care Excellence…

JanssenJohnson & JohnsonNorthern EuropeOncologyPharmaceuticalPricingRegulationUKVelcade

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

14-02-2014

There was further negative news for Germany’s Bayer and partner US health care giant Johnson & Johnson,…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

17-01-2014

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted against…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

J&J’s Janssen units file Citizen Petition with FDA on biosimilars naming

J&J’s Janssen units file Citizen Petition with FDA on biosimilars naming

09-01-2014

Health care giant Johnson & Johnson’s Janssen Pharmaceutical companies have submitted a Citizen Petition…

BiosimilarsGenericsJanssenJohnson & JohnsonNorth AmericaRegulationUSA

UK’s NICE draft guidance negative on Stelara for psoriatic arthritis

UK’s NICE draft guidance negative on Stelara for psoriatic arthritis

27-12-2013

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has opened a consultation…

Anti-Arthritics/RheumaticsEuropeJanssenJohnson & JohnsonPharmaceuticalPricingRegulationStelara InjectionUK

US FDA calls for more data on Janssen’s fixed dose diabetes drug

US FDA calls for more data on Janssen’s fixed dose diabetes drug

16-12-2013

US health care giant Johnson & Johnson has received a complete response letter from the Food and Drug…

canagliflozinDiabetesJanssenJohnson & JohnsonmetforminNorth AmericaPharmaceuticalRegulation

J&J’s Invokana approved in Europe and Olysio cleared in USA

J&J’s Invokana approved in Europe and Olysio cleared in USA

25-11-2013

It was a good news day for US health care giant Johnson & Johnson, with two of its Janssen subsidiaries…

Anti-viralsDiabetesEuropeInvokanaJanssenJohnson & JohnsonMedivirNorth AmericaOlysioPharmaceuticalRegulation

Unanimous FDA panel backing for Janssen’s simeprevir for hep C

Unanimous FDA panel backing for Janssen’s simeprevir for hep C

25-10-2013

Janssen announced yesterday that the FDA's Antiviral Drugs Advisory Committee unanimously recommended…

Anti-viralsJanssenJohnson & JohnsonMedivirNorth AmericaPharmaceuticalRegulationsimeprevir

Janssen files for simultaneous US and EU approval for Castleman disease drug

04-09-2013

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

EuropeJanssenJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRare diseasesRegulationsiltuximab

Setback for Janssen and Bayer's Xarelto as FDA calls for more info in stent thrombosis setting for ACS patients

01-07-2013

Janssen Research & Development, a unit of US health care giant Johnson & Johnson (NYSE: JNJ) revealed…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

Johnson & Johnson expects 10 NDA filings by 2017, saying pharma sector poised for growth

24-05-2013

At a meeting today with industry analysts, senior leaders from the Janssen pharmaceutical companies of…

FinancialJanssenJohnson & JohnsonPharmaceuticalRegulationResearch

J&J's daratumumab gets "Breakthrough" status; GSK's trametinib delayed by FDA

02-05-2013

The US Food and Drug Administration has granted "Breakthrough Therapy Designation" for health care giant…

daratumumabGenmabGlaxoSmithKlineJanssenJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRegulationtrametinib

Pharmacyclics and Janssen gain third FDA "Breakthrough" designation for ibrutinib; new Ph II data

09-04-2013

Pharmacyclics (Nasdaq: PCYC) saw its shares gain 4.5% to $78.96 in early trading Monday, after it revealed…

ibrutinibJanssenJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationResearch

Janssen gains FDA approval of Invokana for type 2 diabetes; files simeprevir NDA

02-04-2013

There were a couple of good news items for Johnson & Johnson (NYSE: JNJ) unit Janssen Pharmaceuticals…

Anti-viralsDiabetesInvokanaJanssenJohnson & JohnsonMedivirNorth AmericaPharmaceuticalRegulationsimeprevirTMC435

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