Month: October 2025

Knowing What Cidara Therapeutics is Doing for the Seasonal Flu

Cidara Therapeutics Cidara Therapeutics (CDTX) is using its proprietary Cloud break® platform to develop novel drug-Fc conjugate (DFC) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment. Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In . . . This content …

BridgeBio Pharma Reported Positive Phase 3 Results from FORTIFY the Phase 3 Pivotal Study of BBP-418 in People with Limb-Girdle Muscular Dystrophy Type 2I/R9

BridgeBio Pharma BridgeBio Pharma, Inc. is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. The Company was founded in 2015. Its team of experienced drug discoverers, developers and innovators is committed to applying advances in genetic medicine …

The U.S. FDA Approved GSK Product Blenrepis for Treatment of Relapsed/Refractory Multiple Myeloma

GSK US FDA Approval Yesterday, October 23, 2025, GSK plc (GSK) announced the United States Food and Drug Administration (FDA) has approved Blenrep in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI

 The FDA Approves Roche’s Gazyva/Gazyvaro for the Treatment of Lupus Nephritis

Roche in the NEWS  Roche (RHHBY) announced Food and Drug Administration approval  of Gazyva®/Gazyvaro®(obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. Following four initial doses in the first year, Gazyva/Gazyvaro can be administered twice yearly, offering an . . . This …

U.S. FDA Approves Boehringer Ingelheim’s JASCAYD® (nerandomilast) Tablets as First New Treatment for Adults with Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim USFDA Approval Boehringer Ingelheim JASCAYD® (nerandomilast) tablets are  approved by the U.S. FDA as an oral treatment for idiopathic pulmonary fibrosis (IPF) in adult patients. JASCAYD is the first and only preferential inhibitor of phosphodiesterase 4B (PDE4B) to be approved in this indication. This represents a novel mechanism of action that exerts both antifibrotic and immunomodulatory effects, thereby slowing the decline in lung …

Why GRAL is Moving UP More Than Usual Today

Samsung and GRAIL Announce Strategic Collaboration  to Bring GRAIL’s Galleri® Multi-Cancer Early Detection Test to Asia Today, October 16, 2025, Samsung C&T (SCT), Samsung Electronics (SEC), and GRAIL, Inc. (GRAL) announced signing a binding Letter of Intent for a strategic collaboration to bring GRAIL’s GalleriⓇ multi-cancer early detection (MCED) test to . . . This content is for paid subscribers. Please click here to subscribe or …

Regeneron: DB-OTO Results in Sustained Improvement in Hearing and Speech Perception in Children with Profound Genetic Hearing Loss

The Great Story from Regerneron Pharmaceuticals Regeneron Pharmaceuticals (REGN) announced updated data for the Company’s  investigational gene therapy DB-OTO for profound genetic hearing loss due to variants of the otoferlin (OTOF) gene were. The investigation has been published in The New England Journal of Medicine and presented during oral presentation at the annual American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNSF) meeting. The latest results from the pivotal CHORD trial …

U.S. FDA Lifts Clinical Hold on NUZ-001, Neurizon® Lead Investigational Therapy for ALS  

Neurizon Therapeutics in the NEWS Today October 6, 2025, from Melbourne, Australia: Neurizon Therapeutics Limited (ASX: NUZ & NUZOA), and U.S (ECQO.F), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to announce that the U.S. FDA has lifted the clinical hold on its lead investigational drug, NUZ-001. This decision marks a pivotal regulatory milestone for Neurizon and the ALS …