Regulation

CHMP endorses ExCellThera’s stem cell transplantation product

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of conditional marketing authorisation for ExCellThera's cryopreserved haematopoietic stem cell transplantation product, Zemcelpro.

Johnson & Johnson submits sBLA to FDA to extend use of ustekinumab

Johnson & Johnson has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) to extend the use of the human interleukin (IL)-12 and IL-23 antagonist, Stelara (ustekinumab), for paediatric patients aged two and above with moderately to severely active Crohn's disease (CD).

Ferrer’s progressive supranuclear palsy therapy gains FDA fast track status

Ferrer's FNP-223 has secured fast-track designation from the US Food and Drug Administration (FDA), intended to slow down the development of progressive supranuclear palsy (PSP), a neurodegenerative disease.

FDA grants fast-track status to SolasCure’s gel for calciphylaxis ulcers

The US Food and Drug Administration (FDA) has granted fast track designation to SolasCure's investigational Aurase Wound Gel (AWG) for treating calciphylaxis ulcers.

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).