Benzinga.com

Following Positive Phase 2 Results And Orphan Drug Designation, Biodexa's FAP Drug Receives FDA Fast Track Status

Biodexa Pharmaceuticals PLC. (NASDAQ:BDRX), a clinical-stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, received ...
Nasdaq

HOOKIPA Announces First Patient Enrolled in Phase 2 Trial Evaluating HB-200 and Pembrolizumab for Treatment of Head and Neck Cancer and Reports FDA’s Fast Track Designation

First patient dosed with HB-200 and pembrolizumab combination for treatment of 1st-line advanced/metastatic head and neck cancer in Phase 2 arm of ongoing Phase 1/2 trial Fast Track Designation ...
Seeking Alpha

AC Immune’s PI-2620 Tau-PET Diagnostic in Phase 3 Receives Fast Track Designation in Three Neurodegenerative Conditions

PI-2620 is in Phase 3 development in Alzheimer’s disease by AC Immune’s partner, LMI This Fast Track designation applies across Alzheimer’s disease, progressive supranuclear palsy, and corticobasal ...
Business Wire

Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial ...

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson (Janssen), ...
Nasdaq

Cellectar Biosciences Announces Breakthrough Therapy Designation for iopofosine I 131, Reports 83.6% Overall Response Rate from CLOVER WaM Phase 2 Study

Cellectar Biosciences, Inc. has announced that the FDA has granted Breakthrough Therapy Designation for its potential cancer treatment, iopofosine I 131, aimed at relapsed/refractory Waldenstrom ...
Business Wire

Azafaros granted important regulatory designations and clearance by European authorities for global Phase 3 studies, to be initiated in 2025

Clinical Trial Application for global Phase 3 trials with nizubaglustat in GM1/GM2 gangliosidoses and Niemann-Pick Disease Type C approved in multiple European countries, anticipated to begin in Q2, ...
Seeking Alpha

Following Positive Phase 2 Results and Orphan Drug Designation, Biodexa's FAP Drug Receives FDA Fast Track Status

CARDIFF, UK / ACCESS Newswire / February 12, 2025 / Biodexa Pharmaceuticals PLC (BDRX)., a clinical-stage biopharmaceutical company developing a pipeline of innovative products for the treatment of ...