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Pharmacyclics files Imbruvica sNDA for Waldenstrom’s macroglobulinemia

20-10-2014

US drugmaker Pharmacyclics has submitted a supplemental New Drug Application to the US Food and Drug…

ImbruvicaJanssen BiotechJohnson & JohnsonOncologyPharmaceuticalPharmacyclicsRegulationUSA

Pharmacyclics’ Imbruvica gains EU approval for two blood cancers

17-10-2014

US drugmaker Pharmacyclics has received marketing approval from the European Commission for Imbruvica…

EuropeImbruvicaJohnson & JohnsonOncologyPharmaceuticalPharmacyclicsRegulation

US FDA grants approval for Imbruvica for chronic lymphocytic leukemia

US FDA grants approval for Imbruvica for chronic lymphocytic leukemia

29-07-2014

The US Food and Drug Administration has granted USA-based Pharmacyclics approval for Imbruvica (ibrutinib)…

B-cell chronic lymphocytic leukemiaChronic lymphocytic leukemiaDanelle JamesImbruvicaJanssen BiotechOncologyPharmaceuticalPharmacyclicsRegulationUSA

US FDA approves sNDAs for Imbruvica and Azilect

US FDA approves sNDAs for Imbruvica and Azilect

09-06-2014

USA-based Pharmacyclics says that the US Food and Drug Administration has accepted for filing its supplemental…

AzilectImbruvicaNeurologicalOncologyPharmaceuticalPharmacyclicsRegulationTeva Pharmaceutical IndustriesUSA

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

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

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

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

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

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