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 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.
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 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.
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 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 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.
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.
AstraZeneca has received approval from the US Food and Drug Administration (FDA) for Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC).
Sanofi has received a priority review from the US Food and Drug Administration (FDA) for its new drug application (NDA) for venglustat, an oral glucosylceramide synthase inhibitor (GCSi) intended for the treatment of type 3 Gaucher disease (GD3).
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