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FDA sets January decision date for Xalkori in ALK-positive lymphoma

Pfizer Xalkori (crizotinib)

FDA submission is based on results from ADVL0912 and A8081013 studies

EMA fast-tracks review of bluebird bio’s LentiGlobin for sickle cell disease

Bluebird BioGene therapy has been given a PRIME designation

Relief Therapeutics seeks US emergency approval for COVID-19 drug

FDA headquarters White OakIf granted, EUA would give approval for use in severely ill patients with no other treatment options

Shionogi's Gram-negative antibiotic launches in the UK

ShionogiNovel antibiotic is indicated for use against Gram-negative bacterial infections

Roche plans to launch rapid COVID-19 antigen test later this month

Roche Basel SwitzerlandSwiss pharma also intends to file for emergency approval in the US

American Medical Association calls for COVID-19 vaccine development transparency

AMAOrganisation asks FDA to provide transparent information on review plans

US charges Teva for generic drug price-fixing plot

Teva PharmaCompany maintains it has not committed any wrongdoing

FDA grants emergency approval for blood plasma treatments for COVID-19

bloodEmergency approval granted despite concerns from top US health officials

Vertex’s triple combination CF therapy to become available on the NHS

NHS England logoThe drug will immediately become available to thousands of cystic fibrosis patients

Brexit‘Post-Brexit landscape for EU-wide IP Rights: The Story So Far’

Brexit means pharma must review its intellectual property rights across Europe

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