Latest Headlines
-
SN BioScience Received US FDA Orphan Drug Designation For Its Nano Anti-Cancer Drug 'SNB-101' On Gastric Cancer.
12/23/2025
SN Bioscience Inc. (CEO Young Hwan PARK) announced that the FDA had granted Orphan Drug Designation (ODD) on December 10 for gastric cancer (including gastroesophageal junction cancer) to SNB-101 (API: SN-38) which is a polymer nanoparticle drug under phase 1b/2 clinical trial for small cell lung cancer.
-
GC Biopharma Secures IND Approval For Phase 1 Clinical Trial Of COVID-19 mRNA Vaccine In Korea
12/22/2025
GC Biopharma (006280.KS), a leading global biopharmaceutical company, announced today that Ministry of Food and Drug Safety (MFDS) in South Korea has approved the Investigational New Drug (IND) application for the Phase 1 clinical trial of "GC4006A", mRNA (messenger RNA) vaccine candidate for COVID-19.
-
New ALS Drug Stabilizes Decline With Improved Strength, Mobility For Some
12/22/2025
Historically, people with amyotrophic lateral sclerosis (ALS) experience a relentless decline of neurological function that eventually robs them of the ability to move, speak, eat or breathe.
-
Flagship Pioneering And Repertoire® Immune Medicines Announce Agreement To Identify T Cell-Targeted Immune Medicines For Prostate Cancer Under Strategic Partnership With Pfizer
12/22/2025
Flagship Pioneering, a scientific innovation engine for transformative platforms and products, today announced a research program under its strategic collaboration with Pfizer whereby Flagship-founded Repertoire® Immune Medicines will identify and optimize TCR bispecifics for metastatic prostate cancer.
-
Breakthrough Set To Accelerate Osteoporosis Drug Development
12/22/2025
Millions of osteoporosis patients worldwide are set to benefit from a major international breakthrough which will transform how new treatments for the debilitating disease are developed.
-
Egetis Therapeutics Initiates New Drug Application In The USA For Emcitate (Tiratricol) For MCT8 Deficiency
12/19/2025
Egetis Therapeutics AB (publ) (“Egetis” or the “Company”), today announced that the Company has initiated a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for Emcitate (tiratricol), its investigational drug for the treatment of MCT8 deficiency.
-
Beren, Through Its Subsidiary Mandos, Submits New Drug Application To U.S. FDA For Adrabetadex In Infantile-Onset NPC
12/19/2025
Beren Therapeutics P.B.C. (“Beren”) today announced that its subsidiary Mandos LLC (“Mandos”) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for adrabetadex, an investigational therapy for the treatment of infantile-onset Niemann-Pick disease type C (NPC).
-
Accelerating Next-Generation Drug Discovery With Click-Based Construction Of PROTACs
12/18/2025
In 2001, chemists K. Barry Sharpless, Hartmuth C. Kolb, and M. G. Finn introduced click chemistry, a concept in which organic molecules can be rapidly and reliably joined to form more complex structures. They recognized that many natural compounds are assembled through efficient carbon-heteroatom (C-X) bond formation, particularly with nitrogen, oxygen, and sulfur, and they sought to replicate this in the laboratory.
-
Meiji Seika Pharma Partners With MBC Biolabs To Strengthen Global Innovation In Drug Discovery
12/18/2025
Meiji Seika Pharma Co., Ltd. (Headquarters: Chuo-ku, Tokyo; President & CEO: Toshiaki Nagasato) today announced that it has entered into a partnership agreement with MBC BioLabs which is a private organization supporting the development of biotech startup companies in California’s San Francisco Bay Area.
-
Cartography Receives FDA Investigational New Drug (IND) Approval And Fast Track Designation For Lead Program CBI-1214 For Colorectal Cancer
12/18/2025
Cartography Biosciences, Inc., a biotechnology company advancing a differentiated pipeline of antibody-based cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for its lead program, CBI-1214.