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- PMLiVE

Monkeypox

- 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

Bristol-Myers Squibb (BMS) building

BMS bags US approval for Opdivo and Yervoy combo

Marks first approval for joint use of two immuno-oncology drugs

- PMLiVE

Merck gets lung cancer OK for Keytruda in US

Highlights increased understanding of molecular processes in cancer

Sanofi reception

Sanofi’s lixisenatide is back under FDA review

Brings GLP-1 agonist closer to US market

- PMLiVE

FDA clears Taiho’s oral colorectal cancer drug

Regulatory nod for Lonsurf gives patients additional treatment options

- PMLiVE

Amgen granted priority review for extended use of Kyprolis

Trial data shows myeloma drug's improvement over Velcade

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