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- PMLiVE

FDA clears first brain test to diagnose ADHD in children

NEBA system available as part of wider clinical assessment

- PMLiVE

Boehringer breaks into oncology with FDA approval

Agency backs company's first cancer drug afatinib in lung cancer

- PMLiVE

EMA in firing line as transparency debate widens

Swedish regulator claims EU agency withheld information on drug withdrawn from sale in 2008

- PMLiVE

GSK files combination skin cancer drug in US

Seeks FDA approval for Tafinlar - Mekinist combination in melanoma

AZ target Omthera files blood fat drug in US

FDA submission for Epanova in severe hypertriglyceridemia

- PMLiVE

Lilly/ Boehringer’s Lantus biosimilar accepted for EMA review

Moves pharma companies’ version of Sanofi's blockbuster insulin a step closer to approval

Croatia joins European medicines network

Follows country's membership of the European Union

- PMLiVE

Roche’s Perjeta on US fast-track for early breast cancer

FDA grants priority review for drug's use before surgery

- PMLiVE

FDA forces Achillion to delay hepatitis C programme

Abnormal liver functions detected in some patients taking sovaprevir

- PMLiVE

Setback for Merck & Co as FDA knocks back insomnia drug

US regulator asks for company to file for approval of a lower starting dose of suvorexant

- PMLiVE

GSK’s personalised cancer drug Tafinlar set for European approval

Regulatory advisors recommend the melanoma drug be licensed

- PMLiVE

First mAb biosimilars set for European approval

Celltrion and Hospira's versions of J&J's blockbuster Remicade recommended by CHMP

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