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- PMLiVE

Raxone

- 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

EU flag

CHMP backs two rare disease therapies at April meeting

Biogen's Spinraza and BioMarin's Brineura near EU approval

Actelion HQ Switzerland

EU nod for Actelion’s skin cancer drug Ledaga

Still need to meet CHMP post-approval requirements

- PMLiVE

J&J gets CHMP backing for broader Darzalex use

Recommendation for earlier-stage approval could see multiple myeloma drug reach blockbuster sales

- PMLiVE

AZ nears EU approval for hyperkalaemia drug Lokelma

CHMP adopts positive opinion for the potassium-binding treatment

- PMLiVE

Marathon pauses Emflaza launch amid pricing furore

US Senator Bernie Sanders calls Duchenne muscular dystrophy drug’s pricing “unconscionable”

- PMLiVE

FDA approves first steroid for Duchenne muscular dystrophy

Marathon Pharma’s Emflaza is first approved to treat all genetic forms of the condition

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