Regulation

Japan approves Sanofi’s Sarclisa combo for MM treatment

Sanofi has received approval from Japan’s Ministry of Health, Labour and Welfare for its subcutaneous (SC) formulation of Sarclisa (isatuximab) in combination with standard therapies to treat multiple myeloma (MM).

Alkermes’ alixorexton secures FDA and EC orphan designations

Alkermes has received orphan drug designations (ODD) from both the US Food and Drug Administration (FDA) and the European Commission (EC) for alixorexton, its investigational oral orexin 2 receptor (OX2R) agonist to treat idiopathic hypersomnia (IH) and narcolepsy.

ALK’s EURneffy secures MHRA approval for anaphylaxis treatment

ALK has received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for EURneffy 1mg, a needle-free adrenaline treatment for children with anaphylaxis.

FDA grants priority review for Roche’s Tecentriq combo sBLA

Roche has received the US Food and Drug Administration (FDA) priority review for its supplemental biologics licence application (sBLA) for adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy for colon cancer.

Pfizer’s Hympavzi secures FDA expanded indications for haemophilia

Pfizer has received approval from the US Food and Drug Administration (FDA) for an expanded indication of Hympavzi (marstacimab-hncq) for the treatment of haemophilia A or B.

EC grants marketing authorisation for IntraBio’s Aqneursa

The European Commission (EC) has granted marketing authorisation for IntraBio’s Aqneursa (levacetylleucine) to treat neurological symptoms of Niemann-Pick disease type C (NPC).

Biogen’s salanersen gains FDA breakthrough therapy designation for SMA

Biogen has received the breakthrough therapy designation from the US Food and Drug Administration (FDA) for salanersen (BIIB115), an investigational treatment for spinal muscular atrophy (SMA).

AbbVie receives EC approval for Aquipta to treat migraine

AbbVie has received approval from the European Commission (EC) for Aquipta (atogepant), an oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine in adults, with or without aura.

Roche’s giredestrant secures FDA priority review for breast cancer

The US Food and Drug Administration (FDA) has accepted priority review of the new drug application (NDA) for Roche’s investigational oral selective oestrogen receptor degrader (SERD), giredestrant, for breast cancer.