Regulation - Approvals

China’s NMPA approves AstraZeneca and Merck’s Lynparza for ovarian cancer

China’s National Medical Products Administration (NMPA) has approved AstraZeneca and Merck’s (known as MSD outside of the US and Canada) Lynparza (olaparib) as maintenance therapy for a type of ovarian cancer.

Lilly’s Retevmo receives FDA approval to treat solid tumours

Eli Lilly and Company (Lilly) has received the US Food and Drug Administration (FDA) approval for its RET kinase inhibitor, Retevmo (selpercatinib), to treat advanced or metastatic solid tumours in adult patients.

Alnylam receives EU marketing authorisation for hATTR amyloidosis therapy

Alnylam Pharmaceuticals has received marketing authorisation from the European Commission (EC) for RNAi therapeutic, Amvuttra (vutrisiran), to treat hereditary transthyretin-mediated (hATTR) amyloidosis.

Kite’ Yescarta gets CHMP positive opinion to treat large B-cell lymphoma

Gilead company Kite has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its Yescarta (axicabtagene ciloleucel) to treat large B-cell lymphoma.

US FDA approves Mallinckrodt’s Terlivaz for injection to treat hepatorenal syndrome

The US Food and Drug Administration (FDA) has approved Mallinckrodt’s Terlivaz (terlipressin) for injection to treat hepatorenal syndrome (HRS).

AnHeart, NewG Lab receive orphan drug designation in Korea for NSCLC therapy

AnHeart Therapeutics and NewG Lab Pharma subsidiary NewG Lab Therapeutics have received orphan drug designation in Korea for the next-generation tyrosine kinase inhibitor (TKI), taletrectinib, to treat advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

US FDA approves Revance’s Daxxify for injection to treat frown lines

The US Food and Drug Administration (FDA) has approved Revance Therapeutics’ Daxxify (DaxibotulinumtoxinA-lanm) for injection to temporarily improve moderate to severe frown lines (glabellar lines) in adults.

China’s NMPA approves AstraZeneca’s Forxiga to treat chronic kidney disease

China’s National Medical Products Administration (NMPA) has approved AstraZeneca’s Forxiga (dapagliflozin) to treat chronic kidney disease (CKD) in adult patients who are at risk of progression with and without type-2 diabetes (T2D).

Boehringer Ingelheim receives FDA approval for GPP flares therapy

Boehringer Ingelheim has received the US Food and Drug Administration (FDA) approval for its monoclonal antibody, spesolimab, to treat adult patients with generalized pustular psoriasis (GPP) flares.