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

Taiho Pharmaceutical Co., Ltd. (“Taiho”) today announced the discontinuation of the Phase 3 STAR-121 study due to futility. STAR-121 study, which is being conducted in collaboration with Arcus Biosciences, Inc. (“Arcus”) and Gilead Sciences, Inc. (“Gilead”), evaluated the anti-TIGIT antibody domvanalimab (development code: AB154) plus anti-PD-1 antibody zimberelimab (development code: AB122) and chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for metastatic non-smal

– RECIST-based ORR of 38.5% (confirmed) and 46.2% (unconfirmed) – mRECIST-based ORR of 61.5% with a complete response (CR) rate of 23% – No Grade 3 or higher adverse events related to RZ-001 observed – Highlights clinical potential of RNA trans-splicing ribozyme platform technology April 20, 2026 --- Rznomics announced today that it presented interim clinical data from its ongoing study of RZ-001, an RNA editing-based investigational anticancer therapy, in patients with hepatocellular carcinoma

Data demonstrate potent multi-target activity, high specificity, and a novel approach to overcoming fundamental limitations of T cell engagers in solid tumors April 20, 2026 -- Deck Bio, a biotechnology company advancing multi-pMHC targeted T cell engagers for solid tumors, today presented new preclinical data for its lead program, DBXO-1, at the American Association for Cancer Research (AACR) Annual Meeting 2026, which is being held April 17–22 in San Diego, California. The data were included