Regulation - North America, Johnson & Johnson

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Pharmacyclics seeks additional indication for Imbruvica in USA

Pharmacyclics seeks additional indication for Imbruvica in USA

08-04-2014

USA-based Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug…

BiotechnologyImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmacyclicsRegulationUSA

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 expands approval of Imbruvica to treat chronic lymphocytic leukemia

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

13-02-2014

The US Food and Drug Administration yesterday expanded the approved use of US health care giant Johnson…

ImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationUSA

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

FDA acceptance of ibrutinib NDA triggers milestone for Pharmacyclics

30-08-2013

California, USA-based Pharmacyclics (Nasdaq: PCYC) said yesterday (August 29, 2013) that the US Food…

BiotechnologyibrutinibJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulation

Simponi ARIA cleared by US FDA

19-07-2013

US health care giant Johnson & Johnson's (NYSE: JNJ) Janssen Biotech subsidiary has received US Food…

Anti-Arthritics/RheumaticsBiotechnologyJanssen BiotechJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi ARIA

Janssen submits NDA for "breakthrough" leukemia and lymphoma drug ibrutinib

11-07-2013

Janssen Pharmaceuticals, a unit of US health care giant Johnson & Johnson (NYSE: JNJ), has submitted…

ibrutinibJanssen PharmaceuticaJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulation

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

US FDA approves Janssen's Simponi to treat ulcerative colitis

16-05-2013

The US Food and Drug Administration late yesterday (May 15) approved a new use for Johnson & Johnson…

BiotechnologyGastro-intestinalsInflammatory diseasesJanssen BiotechJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi Injection

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 and Genmab's daratumumab fast-tracked by US FDA

03-04-2013

Denmark-based biotech firm Genmab A/S (OMX: GEN) says that the US Food and Drug Administration has granted…

BiotechnologydaratumumabGenmabJanssen BiotechJohnson & JohnsonNorth AmericaOncologyRegulation

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

US FDA grants "breakthrough" status for Janssen and Pharmacyclics ibrutinib

14-02-2013

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development, says that…

BiotechnologyibrutinibJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationResearch

FDA approval of generic cancer drug Doxil is expected to help resolve shortage

06-02-2013

The US Food and Drug Administration has approved the first generic version of the cancer drug Doxil (doxorubicin…

DoxilGenericsJohnson & JohnsonLipodoxNorth AmericaOncologyRegulationSun Pharmaceutical Industries

Regulatory briefs from Astellas, Janssen, Biogen and Elan, and QRxPharma

17-01-2013

The US subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) says the US Food and Drug Administration…

Anti-viralsAstellas PharmaBiogen IdecBiotechnologyElanEuropeJanssenJohnson & JohnsonMoxDuoNeurologicalNorth AmericaOncologyPharmaceuticalPrezistaQRxPharmaRegulationTarcevaTysabri

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

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