Latest News and Press Releases

Want to stay updated on the latest news?

Sign into Reader Account Create Reader Account

October 29, 2025 10:00 ET | Source: Dewpoint Therapeutics

FDA Grants Orphan Drug Designation to Dewpoint Therapeutics’ DPTX3186 for the Treatment of Gastric Cancer

Dewpoint's DPTX3186 receives FDA Orphan Drug Designation for gastric cancer - the first ever granted to a condensate-modulating therapeutic.
October 15, 2025 07:00 ET | Source: Transpire Bio

Transpire Bio Granted Orphan Drug Designation by the U.S. FDA For Two Rare Diseases

Transpire Bio today announced that the U.S. FDA has granted orphan drug designation (ODD) for two of its products in development.
September 04, 2025 07:00 ET | Source: BPGbio

BPGbio Announces Completion of Enrollment for Phase 2b Trial of BPM31510 for Glioblastoma (GBM)

BPGbio Announces Completion of Enrollment for Phase 2b Trial of BPM31510 for Glioblastoma (GBM) and Topline Phase 2b clinical data expected in 1H 2026
July 30, 2025 09:24 ET | Source: Trethera Corporation

FDA Provides Trethera Clearance to Initiate TRE-515 Clinical Trial in Healthy Volunteers to Study Food Effect and Biomarkers

Creates platform for precision dosing, companion diagnostics, streamlined development, and broader use across cancer and autoimmune diseases.
July 30, 2025 07:40 ET | Source: Research and Markets

2 Day FDA (Food and Drug Administration) Drug Approval Process Training Course | Stay Ahead with Insights into IND, NDA, ANDA, and 505(b)(2) Submissions (ONLINE EVENT: October 7-8, 2025)

Dublin, July 30, 2025 (GLOBE NEWSWIRE) -- The "The FDA (Food and Drug Administration) Drug Approval Process Training Course" training has been added to ResearchAndMarkets.com's offering. The US...
June 03, 2025 09:10 ET | Source: Trethera Corporation

Trethera Secures New License, Strengthening TRE-515 Intellectual Property Portfolio and Extending Market Exclusivity to 2045

Global exclusive agreement expands patent coverage for compound structures and autoimmune uses across major pharmaceutical markets
June 03, 2025 06:00 ET | Source: Priothera

Priothera Strengthens Board with Appointment of Industry Veteran, Dr. Hans Menssen

Highly experienced clinical development executive joins Priothera Board as mocravimod progresses through global Phase 3 trial as adjunctive and maintenance treatment in AML patients undergoing...
May 21, 2025 09:12 ET | Source: Trethera Corporation

Globally Recognized Expert in Rare Autoimmune Neurologic Diseases, Dr. Benjamin Greenberg, Joins Trethera Scientific Advisory Board

Trethera enlists leading expert in demyelinating diseases to advance TRE-515, a first-in-class drug with FDA Orphan Drug status for ADEM and optic neuritis
May 06, 2025 03:00 ET | Source: Priothera

Priothera Appoints Dr. Jens Hasskarl as Chief Medical Officer to Drive Late-Stage Clinical Development of Mocravimod, a S1P Receptor Modulator for Acute Myeloid Leukemia (AML)

Dr. Hasskarl to lead global Phase 3 MO-TRANS study evaluating mocravimod as an adjunctive treatment to allo-HCT in AML Saint-Louis, France and Dublin, Ireland – 6th May 2025– Priothera Ltd., a...
April 23, 2025 12:59 ET | Source: AB Science

La molécule AB8939 obtient la désignation de médicament orphelin auprès de l'EMA dans le traitement de la leucémie myéloïde aigue

COMMUNIQUE DE PRESSE LA MOLECULE AB8939 OBTIENT LA DESIGNATION DE MEDICAMENT ORPHELIN DANS L’UNION EUROPEENNE AUPRES DE L’AGENCE EUROPEENNE DES MEDICAMENTS (EMA) DANS LE TRAITEMENT DE LA LEUCEMIE...