Regulation

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).

FDA grants fast track status to Alterity’s multiple system atrophy treatment

The US Food and Drug Administration (FDA) has granted fast track designation to Alterity Therapeutics' oral agent ATH434 for treating multiple system atrophy (MSA).

CHMP endorses Roche’s breast cancer therapy for administration out of clinical settings

Roche has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for updating the European Union (EU) label of Phesgo.