Regulation

FDA approves Novartis’ Tafinlar + Mekinist combination therapy

The US Food and Drug Administration (FDA) has granted accelerated approval to Novartis’ combination therapy Tafinlar (dabrafenib) + Mekinist (trametinib) to treat solid tumours.

FDA approves Ellipses’ application for advanced RET-altered cancer treatment

The US Food and Drug Administration (FDA) has approved Ellipses Pharma’s investigational new drug (IND) application for EP0031 (A400) to treat advanced RET-altered cancers.

EC approves variation of Rhythm’s Imcivree to treat renal impairment patients

The European Commission (EC) has authorised a variation of Rhythm Pharmaceuticals’ Imcivree (setmelanotide) to treat patients with mild, moderate or severe renal impairment.

VBI Vaccines gets orphan drug designation for glioblastoma therapy

VBI Vaccines has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for VBI-1901 to treat glioblastoma (GBM), a most common primary brain cancer.

AbbVie submits sNDA to FDA for atogepant label expansion

AbbVie has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for atogepant (Qulipta) to support the label expansion to treat chronic migraine in adults.

FDA approves AbbVie’s Skyrizi to treat Crohn’s Disease in adults

The US Food and Drug Administration (FDA) has approved AbbVie’s approved Skyrizi (risankizumab-rzaa) for the treatment of Crohn's disease (CD) in adults.

Eli Lilly, Incyte receive FDA approval for severe alopecia areata medicine

Eli Lilly and Incyte have received the US Food and Drug Administration (FDA) approval for Olumiant (baricitinib) to treat adult patients with severe alopecia areata (AA).

Roche receives EU marketing authorisation for follicular lymphoma treatment

Roche has received conditional marketing authorisation from the European Commission (EC) for Lunsumio (mosunetuzumab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).

FDA approves Sanofi and Regeneron’s Dupixent for atopic dermatitis

The US Food and Drug Administration (FDA) has granted approval for Sanofi and Regeneron’s Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis in children aged six months to five years.