Regulation - Boehringer Ingelheim, Oncology

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UK NICE recommends Giotrif and Velcade, but says “no” to added use of Alimta

23-04-2014

People in England and Wales with lung cancer whose tumors test positive for a mutation will now have…

AlimtaBoehringer IngelheimEli LillyGiotrifJohnson & JohnsonNorthern EuropeOncologyPharmaceuticalPricingRegulationUKVelcade

Boehringer Ingelheim’s volasertib granted orphan drug designation for AML

Boehringer Ingelheim’s volasertib granted orphan drug designation for AML

17-04-2014

The US Food and Drug Administration and the European Commission have granted German family-owned drug…

Boehringer IngelheimEuropeGermanyHealth Medical PharmaMajorMedicineOncologyPharmaceuticalPharmacologyRegulationUS Food and Drug AdministrationUSAvolasertib

NICE draft guidance recommends Boehringer Ingelheim’s Giotrif

NICE draft guidance recommends Boehringer Ingelheim’s Giotrif

17-03-2014

UK drugs watchdog the National Institute for Health and care Excellence (NICE) this morning issued new…

Boehringer IngelheimGiotrifNorthern EuropeOncologyPharmaceuticalPricingRegulationUK

IQWiG finds that added benefit of Boehringer’s Giotrif depends on mutation status

IQWiG finds that added benefit of Boehringer’s Giotrif depends on mutation status

19-02-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG), in an early benefit assessment…

Boehringer IngelheimGermanyGiotrifNorthern EuropeOncologyPharmaceuticalPricingRegulation

Boehringer files for EU approval of nintedanib

Boehringer files for EU approval of nintedanib

15-10-2013

Boehringer Ingelheim has submitted a Marketing Authorization Application to the EMA for the approval…

Boehringer IngelheimEuropenintedanibOncologyPharmaceuticalRegulation

Boehringer Ingelheim gets Breakthrough designation for leukemia candidate

17-09-2013

German pharma major Boehringer Ingelheim has gained Breakthrough Therapy Designation from the US Food…

Boehringer IngelheimEuropeOncologyPharmaceuticalRegulationvolasertib

Germany's Bayer and Boehringer both get CHMP backing

29-07-2013

Among a string of positive recommendations revealed last Friday (July 26) by the European Medicines Agency's…

afatinibBayerBoehringer IngelheimEuropeEyleaGiotrifOncologyOphthalmicsPharmaceuticalRegulation

US FDA approves Boehringer Ingelheim's first cancer drug

15-07-2013

In what the family-owned German drug major Boehringer Ingelheim hopes is just the first drug to come…

afatinibBiotechnologyBoehringer IngelheimGilotrifNorth AmericaOncologyPharmaceuticalQiagenRegulation

US FDA approves companion diagnostic for Tarceva, and new indication for the Roche drug

15-05-2013

The US Food and Drug Administration late yesterday (May 14) approved Swiss drug major Roche (ROG: SIX)…

Boehringer IngelheimNorth AmericaOncologyPharmaceuticalQiagenRegulationRocheTarcevaTomtovok

Boehringer Ingelheim's afatinib NDA gets priority review in USA

16-01-2013

The US subsidiary of German independent drug major Boehringer Ingelheim revealed yesterday that the New…

afatinibBoehringer IngelheimNorth AmericaOncologyPharmaceuticalQiagenRegulationTomtovok

Boehringer Ingelheim files first oncology compound, afatinib, for EU approval

21-09-2012

German family-owned drug major Boehringer Ingelheim said yesterday that it has submitted a Marketing…

afatinibBoehringer IngelheimEuropeOncologyPharmaceuticalRegulation

Caelyx and Ceplene manufacturing should be moved, says EMA

18-03-2012

The European Medicines Agency has recommended that the manufacturing processes for the anticancer medicines…

Boehringer IngelheimCaelyxCepleneEpiCeptJanssen-CilagJohnson & JohnsonOncologyPharmaceuticalRegulationRespiratory and Pulmonary

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