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- PMLiVE

Somatuline Depot

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US approval for Novo’s Factor XIII drug Tretten

Becomes first recombinant treatment licensed for a rare clotting disorder

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Janssen’s Sirturo wins backing for conditional EU licence

CHMP recommends first-in-class multidrug-resistant tuberculosis treatment

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FDA backs a brace of allergy immunotherapies

Merck & Co and Stallergenes win drug approvals in US

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Senior hire for 3D Communications

Allison May Rosen joins as communications lead for FDA Advisory Committee projects

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FDA panel backs Takeda’s inflammatory bowel disease drug

Vedolizumab on course for US approval to treat Crohn’s disease and ulcerative colitis

FDA reins in Google-backed genetics company 23andMe

Health-related genetic test service put on hold pending US regulatory review

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Auxilium’s Xiaflex cleared in US for erection disorder

FDA approval to treat Peyronie's disease

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EMA: more fee reductions for orphan drugs

Greater incentives introduced for larger companies

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Baxter re-files HyQvia for immunodeficiency in US

Pharma company provides FDA with more data

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FDA backs new formulation of Noxafil

Merck wins US approval for delayed-release version of anti-infective

The logistics of orphan drugs

Managing a rare disease global access programme, the goal is to minimise risk and get the drug to the patient on time

- PMLiVE

FDA lifts restrictions on Avandia use

US regulator says GSK’s diabetes drug does not increase heart attack risk

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