Approvals

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.

US FDA approves GSK’s MMR vaccine Priorix

The US Food and Drug Administration (FDA) has approved the use of GSK’s Priorix to prevent measles, mumps and rubella (MMR) in children aged 12 months and older.

China’s NMPA approves CStone’s sugemalimab for NSCLC treatment

China’s National Medical Products Administration (NMPA) has approved CStone Pharmaceuticals’ sugemalimab (Cejemly) for unresectable stage III non-small cell lung cancer (NSCLC) treatment.

VBI Vaccines’ hepatitis B vaccine gets UK MHRA marketing authorisation

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to VBI Vaccines’ PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)].

US FDA grants Breakthrough Therapy designation to haemophilia A treatment

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Swedish Orphan Biovitrum (Sobi) and Sanofi’s efanesoctocog alfa (BIVV001) to treat haemophilia A.