Regulation - Janssen Biotech

Filter

Current filters:

Janssen Biotech

Popular Filters

EMA’s CHMP backs approval of two new treatment options for rare cancers

EMA’s CHMP backs approval of two new treatment options for rare cancers

26-07-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use, at its July meeting,…

BiotechnologyEuropeFinancialGilead SciencesImbruvicaJanssen BiotechJohnson & JohnsonOncologyRegulationZydelig

FDA backs Janssen’s Sylvant for rare disease

24-04-2014

The US Food and Drug Administration yesterday approved Johnson & Johnson subsidiary Janssen Biotech’s…

Janssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRare diseasesRegulationsiltuximabSylvantUSA

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

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

Johnson & Johnson's Stelara gains FDA approval for psoriatic arthritis

24-09-2013

Janssen Research & Development announced that the US Food and Drug Administration has approved Stelara…

Anti-Arthritics/RheumaticsBiotechnologyJanssen BiotechNorth AmericaRegulationStelara Injection

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

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

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 files BLA for IV form of Simponi for moderate-to-severe RA

20-09-2012

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech has submitted a Biologics…

Anti-Arthritics/RheumaticsBiotechnologyJanssen BiotechJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi Injection

Janssen files Xarelto sNDA for ACS; FDA to review Amgen’s Xgeva for CRPC

30-12-2011

US health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen Research & Development, has submitted…

AmgenBayerBiotechnologyCardio-vascularJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRegulationXareltoXgeva

Company Spotlight

ImmunoGen

ImmunoGen

Back to top