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Eisai gets green light for Lenvima in kidney cancer

New drug awarded breakthrough and priority review status by FDA in RCC

- PMLiVE

FDA approves expanded indication for Gilotrif

US body gives Boehringer Ingelheim’s oral lung cancer treatment the nod

- PMLiVE

FDA panel says no to quick approval of Clovis’ rociletinib

Recommends waiting for phase III trial results after "serious" safety concerns

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AbbVie and Roche to launch Venclexta within a week

FDA approves first-in-class BCL-2 inhibitor to treat chronic lymphocytic leukaemia patients

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FDA panel backs Intercept’s rare liver disease drug

Ocaliva recommended for accelerated approval as a primary biliary cholangitis treatment

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FDA approves first Remicade biosimilar

Pfizer-Celltrion's Inflectra becomes the second biosimilar to be licensed in the US

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Gilead boosts liver disease pipeline with $1.2bn acquisition

Also has combination HIV therapy Descovy approved by FDA

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Jazz Pharma bags FDA approval for rare disease drug

Defitelio given the green light to treat patients who develop severe hepatic VOD

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Nuplazid backed by FDA panel as first-ever Parkinson’s psychosis drug

Concludes Acadia Pharmaceuticals’ drug provides ‘modest but meaningful’ benefits

- PMLiVE

FDA approves new drugs from Teva, Lilly and Elusys

Cinqair, Taltz and Anthim have all been given the green light in the US

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FDA allows accelerated review for rivals to over-priced drugs

Aims to combat growing trend in exploitation of sole-source drug pricing

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Pfizer gets FDA OK for expanded use of lung cancer drug Xalkori

First NSCLC treatment targeting the rare ROS1 mutation to be approved in the US

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