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Valchlor

- PMLiVE

CHMP hands Santhera second ‘no’ in Duchenne muscular dystrophy

Swiss biopharma says it will re-file Raxone for the licence extension

- PMLiVE

CAR-T therapies show long-term benefits in lymphoma

Novartis’ Kymriah and Gilead’s Yescarta both achieve significant complete response in lymphoma patients

- PMLiVE

CHMP recommends Teva’s generic version of Astellas’ Advagraf

Committee backs the drug for transplant rejection prophylaxis

Roche Basel Switzerland

Roche wins CHMP nod for Alecensa licence extensions

Lung cancer monotherapy set for a broader European label

Bayer symbol

Bayer bags speedy US approval for lymphoma drug Aliqopa

FDA decision sets the pharma firm up for a showdown with Gilead's Zydelig

- PMLiVE

NICE backs Cancer Drugs Fund support for Roche’s Gazyvaro

Lymphoma treatment will be used in conjunction with chemotherapy

- PMLiVE

CHMP backs three immuno-oncology drugs for solid tumours

Roche, MSD and Merck/Pfizer are all on course for new European approvals later this year

- PMLiVE

Sanofi and Regeneron win CHMP nod for Dupixent

Atopic dermatitis treatment backed for European approval

- PMLiVE

Samsung Bioepis wins CHMP nod for second Humira biosimilar

In addition to Imraldi the regulatory advisors also backed new medicines from AbbVie and Gilead

- PMLiVE

Merck gets CHMP backing for long-delayed oral MS drug

Cladribine, which will be branded as Mavenclad, was originally rejected by the committee in 2010

Novartis building

Novartis’ Zykadia claims US approval for first-line lung cancer

The Swiss pharma giant’s drug also receives CHMP positive opinion

- PMLiVE

Payback time nears as Sanofi gets CHMP backing for biosimilar Humalog

Panel recommends insulin Lispro Sanofi to treat diabetes

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