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- PMLiVE

adverse events

FDA: Cybersecurity is an ever-present risk for medical devices

US regulator issues new guidance for manufacturers

- PMLiVE

Intercept gets EU nod for rare liver disease therapy

Ocaliva approved as a combination treatment for primary biliary cholangitis

- PMLiVE

Novartis plans filing for lead CAR-T therapy early next year

Shows complete remission for 82 percent of paediatric and young adult B-cell ALL patients

- PMLiVE

Janssen files Stelara follow-up guselkumab in Europe

Trial data shows J&J’s drug is more effective in treating psoriasis than AbbVie’s Humira

Bristol-Myers Squibb (BMS) building

Opdivo gets green light for Hodgkin lymphoma in Europe

Becomes the first PD-1 inhibitor to receive EU licence in this indication

Novartis building

Novartis gets speedy FDA review for midostaurin

Leukaemia treatment could become first targeted therapy for 25 years

- PMLiVE

CHMP recommends Merck & Co’s Lantus biosimilar

Also backs two biosimilar versions of Lilly’s osteoporosis therapy Forteo

Eli Lilly HQ

Lilly bags EU approval for cancer treatment Lartruvo

Licensed for use with doxorubicin for soft tissue sarcoma patients

- PMLiVE

Ready for takeoff?

A new pathway promises expedited approvals for innovative medicines

Celgene building

Celgene engages IBM Watson for patient safety work

Aims to improve its pharmacovigilance methods with a new cloud-based platform

- PMLiVE

EMA starts review of Pfizer and Merck’s PD-L1 inhibitor

Avelumab looks set to be the first new drug to treat Merkel cell carcinoma

- PMLiVE

Access to orphan drugs for rare cancers in EU28

Although the economic burden imposed by rare cancers has not yet been adequately assessed, the treatment burden posed by rare cancers on individuals, societies and healthcare systems make them a...

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