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- PMLiVE

Horizon Pharma

- PMLiVE

FDA panel rejects cardiovascular outcomes claim for Vytorin

Merck & Co fail to convince regulator's advisors

- PMLiVE

Bayer defends Xarelto as pivotal trial scrutinised

ROCKET AF trial results questioned after some INRATIO devices used in testing recalled

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Xalkori set for rapid review in new lung cancer indication

Pfizer could produce first FDA-approved biomarker-driven therapy for ROS1-positive NSCLC

- PMLiVE

First von Willebrand disease therapy heads new FDA approvals

Baxalta's Vonvendi set for an early 2016 launch in the US

Biomarin

FDA panel rejects BioMarin’s muscular dystrophy drug

Fails to convince committee of its safety and efficacy

Bristol-Myers Squibb (BMS) building

Opdivo cleared for kidney cancer and first-line melanoma

First drug to show survival benefit in kidney cancer since 2007

Eli Lilly HQ

FDA clears Lilly’s lung cancer drug Portrazza

First biologic drug to be approved as first-line therapy for NSCLC

- PMLiVE

FDA approves Adapt Pharma’s opioid overdose nasal spray

Narcan aims to curb rise in deaths from opioid abuse

- PMLiVE

FDA clears Takeda’s oral multiple myeloma drug

Ninlaro is the first oral proteasome inhibitor to get a green light from the FDA

- PMLiVE

FDA deems Merck KGaA and Pfizer’s avelumab a breakthrough

Could become first-in-class treatment for Merkel cell carcinoma

Bristol-Myers Squibb (BMS) building

BMS closer to kidney cancer approval for Opdivo

Wins priority review for renal cell carcinoma

Teva Pharma logo

TEVA’s tardive dyskinesia drug wins FDA breakthrough status

SD-809 to be given development incentives

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