– If confirmed by the European Commission, REDEMPLO would be the first and only siRNA medicine authorized in the EU for both genetically confirmed and clinically diagnosed adult patients with FCS – People living with FCS have extremely high triglyceride levels and a substantially higher risk of acute pancreatitis and related long-term complications, often resulting in a reduced quality of life – The CHMP opinion is based on positive results from the Phase 3 PALISADE study where REDEMPLO reduced

April 24, 2026 -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis (OA), will today present positive data from its Phase II study of LEVI-04 in patients with pain and disability due to OA of the knee at OARSI 2026 World Congress on Osteoarthritis being held in West Palm Beach, FL 23-26 April. Levicept has been selected for four presentations including a podium session in which Professor Philip Conaghan MBBS PhD, Director

Arrowhead Pharmaceuticals' therapy for familial chylomicronemia syndrome (FCS) appears to have gained a slight advantage over a competing drug from Swedish Orphan Biovitrum (Sobi) and Ionis Pharmaceuticals after an EMA panel backed approval in patients without the requirement for a genetic test. The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) — disclosed on Friday — means that Arrowhead's small interfering RNA (siRNA) medicine Redemplo (plozasiran) can be use

Sanofi’s tolebrutinib is on track to get an approval in Europe for a type of multiple sclerosis even after receiving a complete response letter from the FDA in December. On Friday, the European Medicines Agency’s human medicines committee recommended approval of the BTK inhibitor for secondary progressive multiple sclerosis (SPMS) without relapses in the past two years. The decision was based in part on data from the Phase 3 HERCULES trial, which showed tolebrutinib delayed time to onset of six

U.S. Food and Drug Administration (FDA) issues Complete Response Letter (CRL) for trenibotulinumtoxinE (TrenibotE) related to manufacturing processes; no additional clinical studies are requested As the leader in neurotoxin development and manufacturing, AbbVie is well positioned to address all comments in a timely manner April 23, 2026 -- AbbVie (NYSE: ABBV) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologic

April 22, 2026 -- Veloxis Pharmaceuticals, Inc. (Veloxis), a global specialty pharmaceutical company part of Asahi Kasei Corporation, announced today that pegrizeprument (also known as VEL-101), a novel investigational maintenance immunosuppressive agent, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prophylaxis of heart allograft rejection in patients receiving a heart transplant. This follows the recent ODD granted for prevention of organ

New preclinical data, independently presented in two posters at the 2026 American Association for Cancer Research (AACR) Annual Meeting, show positive effects of opaganib[1] as potential add-on therapy in models of neuroblastoma (NB) and triple-negative breast cancer (TNBC) The positive NB data from studies undertaken by Penn State University's Jeremy Hengst and Apogee Biotechnology, and funded by the Beat Childhood Cancer Foundation and Four Diamonds, indicate that opaganib may enhance the ther

April 22, 2026 -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the nationwide availability of Agilent Technologies' PD-L1 IHC 22C3 pharmDx, the only companion diagnostic approved by the U.S. Food and Drug Administration (FDA) to identify patients with platinum-resistant ovarian cancer who may be eligible for Merck's KEYTRUDA®.i KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) are the first FDA-

April 22, 2026 -- OrganaBio, LLC ("OrganaBio"), a vertically integrated blood and cell products and services company delivering end-to-end solutions for cell and gene therapy developers, and RxMP Therapeutics, Inc. ("RxMP"), a late pre-clinical development stage therapeutics company developing novel therapies for the rapid control of severe hemorrhage, today announced a manufacturing partnership under which OrganaBio will serve as RxMP's contract manufacturing partner for the cGMP production of

Patient dosing commenced in Wave II, a multicenter Phase 2/3 study evaluating THRV-1268 in genetically confirmed Long QT Syndrome (LQTS) Type 2; enrollment at leading centers throughout the United States is advancing on track. FDA Fast Track Designation granted for THRV-1268 in LQTS Type 2 and Type 3, supporting expedited development of an investigational therapy targeting QTc reduction and arrhythmic risk in genetically defined LQTS populations. April 22, 2026 --- Thryv Therapeutics Inc., a cl