SAB Biotherapeutics Announces Progress on U.S. FDA’s Phased Review of Company’s Groundbreaking DiversitAb™ Platform
- FDA has approved five of seven sections in a rolling submission required for a New Animal Drug Application (NADA)...
- FDA has approved five of seven sections in a rolling submission required for a New Animal Drug Application (NADA)...
Vaxxinity corporate headquarters in Cape Canaveral, Fla. Vaxxinity corporate headquarters in Cape Canaveral, Fla. (Photo: Vaxxinity)CAPE CANAVERAL, Fla., May 09,...
LEIDEN, Netherlands & CAMBRIDGE, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- ProQR Therapeutics NV. (Nasdaq: PRQR) (ProQR), a company dedicated...
Resmetirom new drug application (NDA) filing on track for Q2 2023Resmetirom has received Breakthrough Therapy designation from FDA Multiple resmetirom...
BioEquity Europe 2023Foro Medcap BME 2023 VI Ibero-American Congress CEAPI 2023BIO International Conference 2023Jefferies Healthcare Conference 2023MidCap Paris 2023MADRID and...
Decision Follows Review of Comprehensive Safety Data Package Submitted by the Company Salarius Plans to Meet with FDA to Discuss...
NEW YORK, May 09, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a biotechnology company focused on discovering and...
-- Announced positive data from initial safety portion of CHASE Phase 2b clinical trial of KPI-012; now enrolling primary safety...
First regenerative medicine technology used in battlefield trauma Ukrainian surgeons trained on HAV procedures over video conferencing DURHAM, N.C., May...
Proven Leader in Building Financial Organizations to Prepare Company for Successful Commercialization Planning for Seladelpar Launch as it Completes Development...
Lead-in data from Phase 3 PEAK trial to be presented at the American Society of Clinical Oncology (ASCO) 2023 Annual...
WARMINSTER, Pa., May 09, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical...
Initiated Phase 2 clinical trial for XTX202, a tumor-activated IL-2 Anticipate reporting preliminary Phase 1 safety, PK, PD, and anti-tumor...
New Drug Application for YCANTH™ (VP-102) PDUFA Goal Date of July 23, 2023 - Potential to Become Only FDA-approved Therapy...
On track to provide clinical update from dose-escalation portion of Phase 1 clinical trial of EGFR MasterKey inhibitor BDTX-1535 in...
Trivehexin radiopharmaceuticals being developed for imaging and treatment of cancers expressing αvβ6-integrinPancreatic ductal adenocarcinoma is primary indication due to high...
SIG-002, Sigilon’s lead program for the treatment of diabetes, transitioning to IND-enabling and NHP studies in the second half of...
Newly available preliminary efficacy results of surrogate biomarkers from the ANAVEX®2-73-AD-004 study; allowing initiation of discussions with regulatory agencies for...
MALVERN, Pa., May 09, 2023 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM) (the “company” or Neuronetics”) a commercial stage medical technology...
- Investigational New Drug (IND) application for SNS-101 cleared by U.S. Food and Drug Administration (FDA) with first patient dose...