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Eli Lilly HQ

Lilly closes on US approval of lung cancer drug necitumumab

Indication for NSCLC looking likely after informal panel poll

FDA teams up with PatientsLikeMe for patient data project

Will explore its potential to inform the regulator'approach to risk assessment

Gilead Sciences

Gilead files Complera follow-up with FDA

HIV therapy could be approved in the US by the end of this year

Teva Pharma logo

Teva set for FDA verdict on reslizumab early next year

Ruling for severe asthma therapy Cinquil expected by March 2016

- PMLiVE

Transparency debate extends to rejected drug applications

Claims from the BMJ made in new published study

- PMLiVE

GSK’s new asthma biologic gains FDA panel backing

British firm looking to help shore up its ageing respiratory portfolio 

- PMLiVE

FDA panel backs Sprout Pharma’s ‘female Viagra’

Could be approved for HSDD in pre-menopausal women

- PMLiVE

IQWiG unimpressed with Tresiba for children

German cost watchdog says Novo’s insulin may in fact cause more harm in certain patients

- PMLiVE

FDA gives priority review for Keytruda in lung cancer

The regulator is expected to deliver a verdict by October 2 

Bristol-Myers Squibb (BMS) building

BMS melanoma combo impresses at ASCO

Increases survival in difficult to treat form of skin cancer

- PMLiVE

FDA approves Pfizer’s new cancer pill

Drug was previously approved as an organ rejection treatment

- PMLiVE

Sanofi pays $245m for FDA priority review voucher

PRV reduces review time from ten to six months

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