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- PMLiVE

J&J wins FDA panel backing for hepatitis C drug

Simeprevir would challenge Victrelis and Incivek if approved

- PMLiVE

Ariad tanks as Iclusig trial is halted on safety grounds

Shares fall after leukaemia patients develop blood clots

- PMLiVE

FDA sets up rare disease research fund

Will invest $14m across 15 orphan drug projects

- PMLiVE

GSK and Genmab file Arzerra for first-line use in US

Plans progress to expand the chronic lymphocytic leukaemia drug

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

- PMLiVE

Former FDA head to join J&J

Mark McClellan elected to pharma company’s board

- PMLiVE

Novo Nordisk wins US approval for haemophilia treatment

NovoEight will be launched alongside MixPro device after gaining FDA licence

- PMLiVE

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

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