Approvals

FDA grants fast track designation for HAYA Therapeutics’ HTX-001

HAYA Therapeutics has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational therapy, HTX-001, to treat symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

FDA grants fast track designation for Lundbeck’s Lu AH69593

Lundbeck has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational treatment, Lu AH69593, to treat narcolepsy.

Affinia Therapeutics receives FDA orphan drug designation for AFTX-201

Affinia Therapeutics has received the US Food and Drug Administration (FDA) orphan drug designation for AFTX-201, a treatment in development for BAG3-associated dilated cardiomyopathy (DCM).

FDA grants priority review to Roche’s Gazyva/Gazyvaro for pMN

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental biologics licence application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) to treat adults with primary membranous nephropathy (pMN).

FDA approves MSD’s Keytruda combinations for MIBC

The US Food and Drug Administration (FDA) has approved two of Merck & Co’s (MSD) Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each combined with Padcev (enfortumab vedotin-ejfv), for adults with muscle-invasive bladder cancer (MIBC).

US FDA rejects approval of Unicycive’s kidney disease therapy

The US Food and Drug Administration (FDA) has declined to approve Unicycive Therapeutics’ resubmitted new drug application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.

Anixa Biosciences secures Korean patent for breast cancer vaccine

Anixa Biosciences has secured a patent from the Korean Ministry of Intellectual Property (MOIP) for its breast cancer vaccine technology.

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.