Approvals

Novartis receives EC approval for Jakavi to treat GvHD

Novartis has received approval from the European Commission (EC) for its oral therapy Jakavi (ruxolitinib) to treat patients aged 12 years and above with acute or chronic graft-versus-host disease (GvHD).

Kite’s cell therapy facility gets FDA approval for commercial production

Gilead Company’s subsidiary Kite has received the US Food and Drug Administration (FDA) approval for the commercial production at its new CAR T-cell therapy manufacturing facility in Maryland.

NICE recommends Merck’s tepmetko to treat non-small cell lung cancer

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Merck’s tepmetko (tepotinib) to treat adult patients with advanced non-small cell lung cancer (NSCLC).

EC approves Astellas and Seagen’s bladder cancer treatment

The European Commission (EC) has approved Astellas and Seagen’s padcev (enfortumab vedotin-ejfv) for the treatment of urothelial cancer, a bladder cancer type.

Glenmark gets DCGI nod to carry out Hodgkin’s lymphoma treatment trial

Glenmark Pharmaceuticals’ subsidiary Glenmark Specialty has received the Drugs Controller General of India (DCGI) approval to initiate the Phase I clinical trial of its new small-molecule, GRC 54276, in advanced solid tumours and Hodgkin's lymphoma patients.

Novartis receives approval for PIK3CA-related overgrowth spectrum treatment

Novartis has secured accelerated approval from the US Food and Drug Administration (FDA) for vijoice (alpelisib) to treat PIK3CA-related overgrowth spectrum (PROS) patients.

FDA accepts Regeneron, Sanofi’s Dupixent for priority review

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) supplemental Biologics License Application (sBLA) for priority review.

Everest files NDA in Hong Kong for metastatic breast cancer therapy

Everest Medicines has submitted a new drug application (NDA) in Hong Kong for sacituzumab govitecan (SG) to treat metastatic triple-negative breast cancer (mTNBC).

Abionyx receives ODD for CER-001 to treat LCAT deficiency

Abionyx Pharma has received orphan-drug designation (ODD) from the US Food and Drug Administration (FDA) to the Bio-HDL CER-001 to treat lecithin-cholesterol acyltransferase (LCAT) deficiency.