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- PMLiVE

FDA gives Alexion’s metabolic drug breakthrough status

Reduces requirements for registration, potentially speeding up approval

- PMLiVE

France ignores EMA and suspends Bayer’s Diane 35

National Agency for the Safety of Drugs and Health Products contradicts PRAC verdict

Healthcare at Home and QED partner on orphan diseases

OrphanReach alliance will see companies provide product lifecycle services

Bayer symbol

EMA says Bayer’s Diane 35 should remain on European market

Agency investigation concludes acne treatment's benefits outweigh its risks

Payer focus in the personalised world of oncology and orphan diseases

Personalised medicine is transforming disease understanding and many traditional diagnoses may be fundamentally revised based on the new scientific understanding

Novartis building

Novartis gets FDA green light for new Ilaris indication

Immunotherapeutic wins US approval for severe form of childhood arthritis

- PMLiVE

GSK submits COPD drug in US and EU

Umeclidinium bromide intended as monotherapy for lung condition

- PMLiVE

Court blocks EMA release of pharma company data

AbbVie and InterMune successfully challenge request for trial data for Humira and Esbriet

- PMLiVE

FDA approves drugs for rare genetic liver condition and to reverse anticoagulation

Raptor’s Procysbi and CSL Behring’s Kcentra recommended in US

- PMLiVE

Two new cancer drugs recommended in Europe

CHMP backing for Roche's Erivedge and Astellas' Xtandi

- PMLiVE

EMA refuses to back Pfizer’s Xeljanz in rheumatoid arthritis

Surprise after approvals in US and Japan

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