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- PMLiVE

NePathe

- PMLiVE

FDA approves Janssen’s Yondelis

Provides additional treatment option for softtissue sarcoma

- PMLiVE

Amgen gets FDA nod for virus-based melanoma therapy

Advisory committee votes in favour of drug after three month delay

- PMLiVE

AZ moves a step closer to gout drug approval in US

Final verdict to be delivered in end of December

- PMLiVE

Leo Pharma’s Enstilar approved by FDA

Topical psoriasistreatment given the green light

- PMLiVE

Pfizer’s investigational leukaemia drug wins breakthrough status

Puts inotuzumab ozogamacin in line for development incentives

- PMLiVE

Boehringer’s Praxbind granted accelerated approved by FDA

Reversal agent for anticoagulant Pradaxa given the nod

Shire Basingstoke

FDA grants fast track designation to Shire’s Cinryze

Kidney transplant treatment in line for regulatory assistance

- PMLiVE

FDA deals a big blow to Shire’s late-stage pipeline

Additional data required before firm can apply for re-approval

- PMLiVE

Novo Nordisk finally bags insulin degludec approval in US

Aims to get Tresiba and Ryzodeg back on course 

- PMLiVE

FDA rejects AZ’s diabetes combination

Wants to see more trial data on saxagliptin / dapagliflozin

Eli Lilly HQ

Lilly wins breakthrough designation for breast cancer drug

CDK 4 and 6 inhibitor Abemaciclib's development to be expedited by FDA

- PMLiVE

FDA fast-tracks Merck/Pfizer’s rare skin cancer drug avelumab

Comes a month after drug was given orphan status

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