Regulation - Approvals

Sanofi receives marketing authorisation from EC for Pompe disease therapy

Sanofi has received marketing authorisation from the European Commission (EC) for Nexviadyme (avalglucosidase alfa) to treat the complete spectrum of infantile-onset Pompe disease (IOPD) and late-onset Pompe disease (LOPD).

EMA’s CHMP recommends approval for AbbVie’s axial spondyloarthritis therapy

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of AbbVie’s Rinvoq (upadacitinib) to treat adult patients with active non-radiographic axial spondyloarthritis (nr‑axSpA).

EC approves Novartis’ Cosentyx to treat arthritis in children

The European Commission (EC) has approved the extended use of Novartis’ Cosentyx (secukinumab) to treat childhood arthritic conditions.

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.