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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

Bayer symbol

Bayer nets speedy US review for regorafenib in liver cancer

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

Biogen Idec building

FDA approves Biogen’s Spinraza for spinal muscular atrophy

Analysts predict blockbuster sales as drug is priced at $750,000 for first year of treatment

Roche Basel Switzerland

FDA delays verdict on Roche’s MS drug Ocrevus

Additional manufacturing data postpones US verdict until 28 March 2017

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FDA okays Clovis’ Lynparza rival rucaparib

Analysts predict Rubraca could become a $1.5bn-plus product by 2020

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Making a list and checking it twice…

The promise of mobile health lies not in recording information but in promoting behaviour change

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FDA green light for Pfizer’s eczema drug

Blockbuster-hopeful Eucrisa expected to launch early next year at $580 per 60mg tube

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