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- PMLiVE

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Actelion HQ Switzerland

Actelion gets US green light for new PAH drug Opsumit

Approval will help reduce impact of generic competition for Tracleer

- PMLiVE

Amarin slides as FDA panel votes against fish oil therapy

Advisory committee wants more data on Vascepa

- PMLiVE

Budget deal brings FDA back to life

US Congress agreement allows employees at the regulator to return to work

Orphan drugs: the early access regulatory environment

Despite considerable variation to the rules for unlicensed orphan drugs, there are some clear first steps for a global access programme

- PMLiVE

Former FDA head to join J&J

Mark McClellan elected to pharma company’s board

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Novo Nordisk wins US approval for haemophilia treatment

NovoEight will be launched alongside MixPro device after gaining FDA licence

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Third try for MannKind’s inhaled insulin

Pharma company resubmits regulatory filing for diabetes treatment Afrezza in the US

- PMLiVE

Bayer gets US nod for first-in-class Adempas

FDA clears drug for use in pulmonary artery hypertension

- PMLiVE

US shutdown “hurting business”

But FDA decisions continue to trickle through

- PMLiVE

Swift US approval for Baxter’s nutritional supplement

FDA backs Clinolipid to alleviate shortage of drugs for people unable to eat or drink

- PMLiVE

UCB wins extra Cimzia approval in US

FDA backs drug for use in patients with active psoriatic arthritis 

- PMLiVE

US shutdown threatens to disrupt FDA

Congress failure to agree budget cripples government functions

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