NICE publishes final guidance on new use for Lonsurf

27 January 2021 - NICE has completed its review of trifluridine with tipiracil hydrochloride for the treatment of patients with ...

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European Medicines Agency accepts GBT’s marketing authorisation application for Oxbryta (voxelotor) for the treatment of haemolytic anemia in sickle cell disease

27 January 2021 - Global Blood Therapeutics today announced that the EMA has completed the validation of GBT’s marketing authorisation application ...

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European Commission approves Keytruda (pembrolizumab) as first-line treatment in adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer

26 January 2021 - Keytruda is first checkpoint inhibitor approved in Europe to treat MSI-H or dMMR colorectal cancer. ...

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NICE recommends Revlimid for newly diagnosed multiple myeloma patients

27 January 2021 - Bristol Myers Squibb’s Revlimid (lenalidomide) has received a recommendation from the UK’s NICE for newly diagnosed ...

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NICE publishes second appraisal consultation document for Zytiga

26 January 2021 - NICE has had another look at abiraterone acetate for the treatment of patients with newly diagnosed ...

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Recordati Rare Diseases: Carbaglu (carglumic acid) receives U.S. FDA approval for a new indication to treat acute hyperammonaemia associated with propionic acidemia and methylmalonic acidemia

26 January 2021 - Carbaglu is first and only FDA approved medication for hyperammonaemia associated with these rare conditions. ...

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Vertex announces U.S. FDA acceptance of supplemental new drug application for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 with certain mutations

26 January 2021 - FDA grants priority review of the application and sets a PDUFA target action date of 8 June ...

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Symbicort Turbuhaler approved in China as an anti-inflammatory reliever in mild asthma

26 January 2021 - Symbicort Turbuhaler becomes the first dual-combination therapy approved in China for mild, moderate and severe asthma ...

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Albireo announces U.S. FDA acceptance of new drug application for odevixibat

25 January 2021 - FDA has granted odevixibat fast track, rare paediatric disease and orphan drug designations. ...

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Iterum Therapeutics announces U.S. FDA filing acceptance of new drug application for oral sulopenem

25 January 2021 - If approved, first oral penem in the U.S. and first new oral treatment for uUTIs in over ...

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European Commission approves AbbVie's Rinvoq (upadacitinib) for the treatment of psoriatic arthritis and ankylosing spondylitis

25 January 2021 - Approval is supported by data from three pivotal clinical studies in psoriatic arthritis and ankylosing spondylitis where ...

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EMA publishes agenda for 25-29 January CHMP meeting

25 January 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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Calquence approved in Japan for the treatment of relapsed or refractory chronic lymphocytic leukaemia

25 January 2021 - 88% of patients on Calquence remained free of disease progression after 12 months vs. 68% for ...

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European Commission approves Bavencio (avelumab) for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma

25 January 2021 - BAVENCIO maintenance treatment significantly extended median overall survival versus standard of care in the Phase 3 JAVELIN ...

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FDA grants toripalimab fast track designation for mucosal melanoma

25 January 2021 - Junshi Biosciences announced today that U.S. FDA has granted toripalimab fast track designation for the first-line treatment ...

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