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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

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

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

17-01-2014

Since the US Food and Drug Administration’s breakthrough therapy designation (BTD) was put into effect…

GazyvaGilead SciencesImbruvicaJohnson & JohnsonPharmaceuticalRegulationRocheSovaldiUSA

Pharmacyclics signs deal with Lonza to support manufacturing of Imbruvica

Pharmacyclics signs deal with Lonza to support manufacturing of Imbruvica

13-01-2014

USA-based Pharmacyclics has signed a deal with Swiss chemical supplier Lonza for the commercial and clinical…

ImbruvicaLonzaOncologyPharmaceuticalPharmacyclicsProductionUSA

Janssen and Pharmacyclics’ Imbruvica meets key endpoints early in Phase III leukemia trial

Janssen and Pharmacyclics’ Imbruvica meets key endpoints early in Phase III leukemia trial

08-01-2014

USA-based Pharmacyclics and co-developer Janssen Biotech have announced that an Independent Data Monitoring…

ImbruvicaJanssen BiotechOncologyPharmaceuticalPharmacyclicsResearchUSA

US FDA approves Johnson & Johnson’s Imbruvica for rare blood cancer

US FDA approves Johnson & Johnson’s Imbruvica for rare blood cancer

14-11-2013

The US Food and Drug Administration yesterday approved US health care giant Johnson & Johnson’s Imbruvica…

ibrutinibImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclics

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