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.
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.
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.
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).
The US Food and Drug Administration (FDA) has approved Merck’s anti-PD-1 therapy, Keytruda, to treat advanced endometrial carcinoma patients.
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 and Merck have obtained the US Food and Drug Administration approval for Lynparza (olaparib) to treat early-stage breast cancer.
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).
The European Medicines Agency (EMA) has accepted GlaxoSmithKline’s marketing authorisation application (MAA) for daprodustat to treat anaemia of chronic kidney disease (CKD).
The US Food and Drug Administration (FDA) has declined to grant approval for Gilead Sciences’ investigational therapy lenacapavir for HIV.
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