Regulation - Janssen, North America

Filter

Current filters:

JanssenNorth America

Popular Filters

1 to 25 of 28 results

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

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

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

FDA panel backs J&J diabetes drug Invokana (canagliflozin)

11-01-2013

The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee yesterday…

canagliflozinDiabetesInvokanaJanssenJohnson & JohnsonMitsubishi TanabeNorth AmericaPharmaceuticalRegulation

Janssen's TB drug Sirturo gains US FDA approval

02-01-2013

The US Food and Drug Administration has granted accelerated approval for US health care major Johnson…

Antibiotics and Infectious diseasesbedaquilineJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSirturo

Janssen files Stelara for active psoriatic arthritis in USA and EU

07-12-2012

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen yesterday submitted a supplemental…

Anti-Arthritics/RheumaticsBiotechnologyEuropeJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationStelara Injection

FDA staffers seem to back safety of Janssen bedaquiline (Sirturo)

27-11-2012

Ahead of the November 28 meeting of the US Food and Drug Administration's Anti-Infective Drugs Advisory…

Antibiotics and Infectious diseasesbedaquilineJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySirturo

FDA expands Bayer/Janssen's Xarelto use to treat, reduce recurrence of blood clots

05-11-2012

The US Food and Drug Administration (FDA) late Friday approved German drug major Bayer's (BAYN: DE) oral…

BayerBiotechnologyCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

Janssen responds to FDA's Xarelto CRL; resubmits sNDA

10-09-2012

Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development, German drug major Bayer's (BAYN:…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

FDA OKs new indication for Janssen's Nucynta and fast tracks Zytiga sNDA

30-08-2012

There were two pieces of good news for US health care giant Johnson & Johnson (NYSE: JNJ) subsidiaries…

BiotechnologyJanssenJohnson & JohnsonNeurologicalNorth AmericaNucyntaOncologyPharmaceuticalRegulationZytiga

US priority review for two Xarelto sNDAs; one dropped

10-07-2012

The US Food and Drug Administration has assigned a priority review designation to the supplemental New…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

Johnson & Johnson units file for new Zytiga use in USA and EU

18-06-2012

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

EuropeJanssenJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRegulationZytiga

1 to 25 of 28 results

Back to top