Regulation - Approvals

Italfarmaco’s Duvyzat gains EC conditional approval for DMD treatment

The European Commission (EC) has granted Italfarmaco a conditional marketing authorisation for its new histone deacetylase (HDAC) inhibitor, Duvyzat (givinostat), to treat Duchenne muscular dystrophy (DMD) in ambulant patients aged six years and older.

Henlius receives ODD for HLX22 from European Commission

Henlius has secured orphan drug designation (ODD) for its anti-HER2 monoclonal antibody, HLX22, from the European Commission (EC) for gastric cancer treatment.

Genentech gains FDA approval for diabetic retinopathy treatment

Roche’s Genentech has gained the US Food and Drug Administration (FDA) approval for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR).

FDA grants fast track status to Zai Lab’s lung cancer treatment

The US Food and Drug Administration (FDA) has granted fast track designation to Zai Lab’s delta-like ligand (DLL3) antibody-drug conjugate (ADC), ZL-1310, for treating extensive-stage small cell lung cancer (ES-SCLC).

FDA grants RMAT to BrainChild Bio’s CAR T-cell therapy for DIPG

BrainChild Bio's B7 homolog 3 (B7-H3) targeting autologous chimeric antigen receptor (CAR) T-cell therapy, BCB-276, has received the regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for treating diffuse intrinsic pontine glioma (DIPG).

FDA to review Regenxbio’s gene therapy BLA for Hunter syndrome

Regenxbio has announced the acceptance of its biologics license application (BLA) by the US Food and Drug Administration (FDA) of its gene therapy clemidsogene lanparvovec (RGX-121) for review to potentially treat Mucopolysaccharidosis II (MPS II), also referred as Hunter syndrome.

InnoCare’s Mesutoclax obtains breakthrough therapy designation in China

InnoCare’s B-cell lymphoma-2 (BCL2) inhibitor, Mesutoclax (ICP-248), has secured breakthrough therapy designation (BTD) from the China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE).

Abeona announces FDA approval for cell-based gene therapy for RDEB patients

Abeona Therapeutics has announced receipt of the US Food and Drug Administration (FDA) approval for gene-modified cellular sheet therapy Zevaskyn for the wound treatment in both adult and paediatric patients suffering from recessive dystrophic epidermolysis bullosa (RDEB), a serious genetic skin condition.

ALX Oncology’s ALX2004 gains FDA IND clearance to treat solid tumours

ALX Oncology has received investigational new drug (IND) application clearance from the US Food and Drug Administration (FDA) for ALX2004, a new antibody-drug conjugate (ADC) aimed at treating solid tumours that express the epidermal growth factor receptor (EGFR).