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Scynexis

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Novartis’ Zykadia nears first-line lung cancer label

Hopes to boost slow second-line sales to compete directly with Pfizer’s Xalkori and Roche’s Alecensa 

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FDA verdict on Pfizer’s breakthrough leukaemia drug due in August

Phase III trials results saw complete remission in 81% of patients in the treatment group

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FDA OKs Valeant’s psoriasis drug Siliq, with black box warning

Suicidal ideation labelling adds to challenge in rivalling Novartis’ Cosentyx and Lilly’s Taltz

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FDA approves first steroid for Duchenne muscular dystrophy

Marathon Pharma’s Emflaza is first approved to treat all genetic forms of the condition

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Amgen’s chronic kidney disease drug Parsabiv cleared in US

Sensipar follow-up is the first therapy to be approved for treatment of sHPT in 12 years

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Cellectis gets FDA nod for ‘off-the-shelf’ CAR-T trial

Investigational New Drug gets go-ahead for trials in patients with two haematological cancers

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Keytruda filed for first- and second-line bladder cancer

Merck & Co hopes to gain advantage over Opdivo and Tecentriq with first-line setting

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Trump talks pricing and manufacturing with pharma

Heads of Celgene, Lilly, Merck & Co, Novartis and trade body PhRMA met at the White House

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FDA approves Synergy’s constipation drug Trulance

Set to launch by March this year, analysts say the CIC therapy could see sales of $450m by 2020

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Merck & Co’s Keytruda muscles further ahead of rivals in lung cancer

Granted accelerated review by FDA for use in combination with chemotherapy

FDA: Cybersecurity is an ever-present risk for medical devices

US regulator issues new guidance for manufacturers

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Bayer nets speedy US review for regorafenib in liver cancer

Priority review in HCC boosts hopes for rejuvenation of Stivarga to combat declining sales

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