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cemiplimab

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AcelRX’s potent opioid tablets set to win FDA backing for pain relief

Panel voted 10 to 3 in favour of the treatment

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Novartis files for approval of MS drug in EU, US

Siponimod could achieve blockbuster status if approved, says analysts

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Insmed claims first FDA okay for limited population antibiotic

Arikayce is cleared to treat lung disease caused by MAC

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FDA approval gained, Pfizer sets sights on first-line NSCLC market

Vizimpro could challenge Tagrisso, survival data will be key

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Alnylam seeks fast-track filing with biomarker data

Early filing reflects FDA desire for faster approvals

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Alexion adds to pipeline with $1.2bn Syntimmune buy

As company prepares for possible loss of patent protection for Soliris

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Imfinzi aces survival challenge in lung cancer

Earlier treatment leads to much extended lives, data suggests

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Roche’s Tecentriq misses survival mark in frontline NSCLC

Keytruda proving hard to beat

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Biotech leaders jump into US free speech debate

Senior biotech execs sign a letter in defence of free speech

Sanofi reception

Sanofi swaps execs with Bayer, looks to staunch diabetes, cardio decline

Dieter Weinand to be based in key US market

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MSD wins key EU approval for Keytruda, Alimta combo

Decision keeps Keytruda well ahead of rival Tecentriq

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FDA gives Loxo breakthrough tag for second cancer drug

US regulatory body to expect a NDA for LOXO-292 in late 2019

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