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- PMLiVE

FDA approves first Remicade biosimilar

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

- PMLiVE

Gilead boosts liver disease pipeline with $1.2bn acquisition

Also has combination HIV therapy Descovy approved by FDA

- PMLiVE

Teva and Takeda appoint head of Japanese generics venture

Hiroshi Matsumori will lead partnership of Teva’s generics portfolio and Takeda brands

- PMLiVE

Jazz Pharma bags FDA approval for rare disease drug

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

- PMLiVE

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

- PMLiVE

FDA allows accelerated review for rivals to over-priced drugs

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

- PMLiVE

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

AstraZeneca AZ global R&D corporate HQ

AZ’s influenza drug fast tracked in US

FDA expedites MEDI8852 to help meet an acute need for new flu treatments

- PMLiVE

FDA clears Imbruvica as chemo alternative for first-line CLL

Johnson & Johnson/AbbVie's first-in-class drug now approved for all CLL patients

Roche Basel Switzerland

Roche chalks up second approval for Gazyva

FDA approves additional indication as a treatment for follicular lymphoma

- PMLiVE

FDA rejects PTC’s application for muscular dystrophy drug

Says Translarna filing not “sufficiently complete” to permit full review

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