Approvals

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.

US FDA approves UCB’s Fintepla to treat epilepsy in children

The US Food and Drug Administration (FDA) has approved UCB’s Fintepla (fenfluramine) oral solution CIV to treat two years and above aged patients who have seizures associated with Lennox-Gastaut syndrome (LGS), a rare childhood epilepsy form.

Roche gets CHMP approval recommendation of combo therapy for lymphoma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Roche’s Polivy (polatuzumab vedotin) and MabThera (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) combination to treat lymphoma.

FDA declines to approve Eli Lilly, Innovent’s lung cancer treatment

The US Food and Drug Administration (FDA) has declined to approve Eli Lilly and Company and Innovent Biologics’ investigational medicine sintilimab injection in combination with pemetrexed and platinum chemotherapy to treat nonsquamous non-small cell lung cancer (NSCLC).