Avenue Therapeutics Announces Regulatory Update Based on Type C Meeting with FDA and Next Steps in the Development of IV Tramadol

As disclosed in September 2022, Avenue received meeting minutes from the FDA regarding a Type A meeting conducted on August 9, 2022, for IV Tramadol. At th...

April 18, 2023 | Tuesday | News
Olaratumab Antibody Licensed from Lilly Demonstrates Proof of Concept as a Theranostic Radiopharmaceutical

In April 2022, Telix secured the exclusive worldwide rights to develop and commercialise radiolabelled forms of olaratumab for the diagnosis and treatment ...

April 17, 2023 | Monday | News
Atmo Biosciences strengthens U.S. focus with new board appointment and establishment of San Diego office

The increased presence in the U.S. comes as Atmo Biosciences prepares to begin a multi-site pivotal study to support a U.S. Food and Drug Administration (F...

April 17, 2023 | Monday | News
IPS HEART receives FDA Rare Pediatric Drug Designations for both of its Stem Cell Drugs for Duchenne Muscular Dystrophy

The FDA has also recently granted an orphan drug designation (ODD) to GIVI-MPC. Current treatments for DMD have limited therapeutic potential as unfortunat...

April 14, 2023 | Friday | News
Initiation of New Patients on Evobrutinib Paused in the U.S.; Fully Enrolled Phase III Evobrutinib Studies Continue

Merck, a leading science and technology company, today announced the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the init...

April 14, 2023 | Friday | News
Fusion Pharmaceuticals Announces IND Clearance for FPI-2068, a Jointly Developed Novel Targeted Alpha Therapy

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medic...

April 13, 2023 | Thursday | Regulatory
Regulus Therapeutics Completes Enrollment in Phase 1b MAD Trial of RGLS8429 for ADPKD Treatment

"Completion of enrollment in the first cohort of the Phase 1b MAD study is an important milestone in the development of this novel treatment for ADPKD," sa...

April 13, 2023 | Thursday | News
OBI Pharma presents OBI-999 combo and Globo H-targeted CAR T-cell immunotherapy posters at AACR 2023

OBI Pharma, Inc. (TPEx: 4174) today announced preclinical data demonstrating significant synergistic effects of OBI-999 and pembrolizumab (anti-PD1 mAb) in...

April 10, 2023 | Monday | News
UM School of Medicine Researchers Chart Path Forward on Developing mRNA Vaccines for Infections Beyond COVID-19

After helping to develop and test new mRNA technologies for COVID-19 vaccines, University of Maryland School of Medicine (UMSOM) researchers and scientists...

April 10, 2023 | Monday | News
FDA Accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

Pfizer Inc. (NYSE:PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) fo...

April 09, 2023 | Sunday | News
Molecular Templates Announces Partial Clinical Hold for Phase 1 Study of MT-0169

Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”),  announced that the U.S. Food and Drug Admini...

April 09, 2023 | Sunday | News
Morphological Profiling: A Scalable Approach to Monitor Immune Cell Activity

Conventional high-content screening experiments typically focus on extracting imaging data relating to predefined, specific features to identify drugs or d...

April 09, 2023 | Sunday | News
Cell Expansion Market Analysis

The rising prevalence of chronic diseases coupled with increasing research activities for cell-based research is found to be the major factor driving the...

April 07, 2023 | Friday | Analysis
Accord BioPharma's Biosimilar Trastuzumab HLX02 BLA Accepted by US FDA

Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, ...

April 06, 2023 | Thursday | News

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