Regulation

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).

US FDA approves Merck’s anti-PD-1 therapy for endometrial carcinoma patients

The US Food and Drug Administration (FDA) has approved Merck’s anti-PD-1 therapy, Keytruda, to treat advanced endometrial carcinoma patients.

FDA extends review period for Incyte’s sNDA for ruxolitinib cream

The US Food and Drug Administration (FDA) has extended the review period for Incyte’s supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura) to treat vitiligo.

AstraZeneca, Merck get FDA approval for Lynparza to treat breast cancer

AstraZeneca and Merck have obtained the US Food and Drug Administration approval for Lynparza (olaparib) to treat early-stage breast cancer.

Janssen submits application to EMA for mantle cell lymphoma therapy approval

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application seeking approval for the new indication of Imbruvica (ibrutinib) plus bendamustine and rituximab (BR) combination from the European Medicines Agency (EMA).