Avobis Bio Earns FDA RMAT Designation for AVB-114 in Crohn’s Perianal Fistulas

Avobis Bio LLC, a clinical-stage company developing implantable cell therapies, announced  that the U.S. Food and Drug Administration ("FDA") has gr...

October 06, 2025 | Monday | News
Leo Cancer Care Partners with TibaRay to Power Next-Gen Upright Radiotherapy with Advanced Linac Technology

Leo Cancer Care announced that it has placed orders for TibaRay's advanced linear accelerators (linacs), which will be evaluated as an upgrade option to th...

October 06, 2025 | Monday | News
Esperion Secures Key Patent Settlement with Dr. Reddy’s, Protecting NEXLETOL and NEXLIZET Until 2040

Esperion announced that it has entered into a settlement agreement with Dr. Reddy’s Laboratories, Inc. and its affiliate Dr. Reddy’s Laborato...

October 06, 2025 | Monday | News
Revvity and Profluent Lead the Next Frontier in Gene Editing with AI-Powered Precision

In conversation with BioPharma BoardRoom, Amanda Haupt, Business Unit Manager for Base Editing at Revvity, shares insights into how the com...

October 06, 2025 | Monday | Interaction
Draig Therapeutics Secures FDA Clearance to Launch Phase 2 Trial of DT-101 for Major Depressive Disorder

DT-101 is designed to allow effective modulation of the AMPA receptor without compromising safety Phase 2 clinical trial initiation anticipated before...

October 03, 2025 | Friday | News
CRYPTICS Study Confirms Efficacy of CLPH-511 Frozen Platelets in Acute Hemorrhage

CRYPTICS study met the primary efficacy endpoint measure, 24-hour chest tube drainage (Difference in LS Means was 142.0 mL; 95.576% confidence interval...

October 02, 2025 | Thursday | News
Galapagos Cell Therapy Division in Play: Board Eyes Binding Bids Within Weeks

Galapagos announced that its Board of Directors (the “Board”) had decided to explore all strategic alternatives for its cell therapy business...

October 02, 2025 | Thursday | News
POP Biotechnologies Secures $2.46M NIH Grant to Advance “Mosaic” Immunotherapy for Alzheimer’s

POP Biotechnologies, Inc. (POP BIO), has been awarded a $2.46M USD grant by the National Institutes of Health (NIH) to pursue development of a “mos...

October 02, 2025 | Thursday | News
Amneal Pharmaceuticals Submits BLA for Omalizumab Biosimilar to XOLAIR®, Developed with Kashiv BioSciences

Amneal Pharmaceuticals, Inc.announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a propos...

September 30, 2025 | Tuesday | News
Harrow to Acquire Melt Pharmaceuticals, Advancing Non-Opioid, Needle-Free Sedation Therapy MELT-300

Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, announced that it has entered into an ag...

September 30, 2025 | Tuesday | News
ADvantage Therapeutics Secures $2.5M NIH Grant to Advance Alzheimer’s Candidate AD04®

ADvantage Therapeutics, Inc., a biotechnology company developing novel therapies for neurodegenerative diseases, announced it has been awarded a $2.5 mil...

September 30, 2025 | Tuesday | News
Sen-Jam and KVK Tech Complete NDA-Ready CMC Package and Submission Batches for SJP-002C

Completion of submission batches and NDA-ready CMC package strengthens regulatory foundation for upcoming Phase 2b/3 trials and underscores Sen-Jam's lea...

September 29, 2025 | Monday | News
AstraZeneca Launches AstraZeneca Direct to Expand Affordable Access to Medicines with Home Delivery

AstraZeneca announces the launch of AstraZeneca Direct, an online platform designed to create a simple, convenient way for eligible patients to access th...

September 29, 2025 | Monday | News
ME Therapeutics Secures U.S. Patent for Lead G-CSF Antibody Candidate to Advance Cancer Immunotherapies

ME Therapeutics Holdings Inc. a publicly listed biotechnology company working on novel cancer fighting drugs in the field of immuno-oncology, is pleased ...

September 29, 2025 | Monday | News

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