Approvals

BMS secures FDA accelerated approval for Zenbexus in multiple myeloma

The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s (BMS) Zenbexus (iberdomide), along with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd), to treat adult multiple myeloma (MM) patients.

Akeso secures China NMPA authorisation for ivonescimab combo

Summit Therapeutics’ partner Akeso has secured China’s National Medical Products Administration (NMPA) authorisation for the use of ivonescimab in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (NSCLC) patients.

Amgen’s Repatha receives positive CHMP opinion for broader cardiovascular use

Amgen has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Repatha (evolocumab) supporting its broader use prior to a first heart attack or stroke.

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.