The launch follows Dr. Reddy’s receipt of the Notice of Compliance (NOC) from Health Canada on April 28th, 2026, marking the company’s re...
Clearance Recognises CellDx-Tissue's Dual-Analyte DNA and RNA Workflow Across 517 Cancer-Associated Genes, with ALK, RET and ROS1 Fusion Calls on RNA-Lev...
From advanced biologics and cell therapies to increasingly stringent regulatory expectations, today’s pharmaceutical manufacturing environments dem...
Gyre Therapeutics, Inc. (“Gyre”, “Gyre Therapeutics” or the “Company”) (Nasdaq: GYRE), an innovative, commercial-stag...
Jakafi XR is a once-daily, film-coated, extended-release formulation of Jakafi®(ruxolitinib) Once-daily Jakafi XR was shown to provide consisten...
Central nervous system (CNS) cancers remain among the most difficult diseases to treat in oncology, with limited therapeutic options, complex deliv...
Santhera Pharmaceuticals (SIX: SANN) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA...
Significant improvements as early as Week 1, favorable safety profile and no liver safety concerns in REMIX 1 & 2 studies ...
U.S. Food and Drug Administration (FDA) issues Complete Response Letter (CRL) for trenibotulinumtoxinE (TrenibotE) related to manufacturing processes; ...
WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that three of its manu...
Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial Building on the existing indica...
Bavarian Nordic A/S announced that the Swiss Agency for Therapeutic Products, Swissmedic, has approved VIMKUNYA® (recombinant, adsorbed) for active i...
Received FDA Fast Track Designation for pevifoscorvir sodium for the treatment of chronic hepatitis B virus infection HBeAg- cohort sample size increa...
Regulatory submission filed to initiate a Phase 2a trial of its drug candidate, PTI5803 in patients with focal cortical dysplasia (FCD), a rare and sev...
© 2026 Biopharma Boardroom. All Rights Reserved.
