Recce Pharmaceuticals' Topical Gel R327G Reaches Midpoint in Phase II Trial
Recce Pharmaceuticals has reached the midpoint in its Phase II clinical trial for topical gel R327G, aimed at treating skin infections.
Walgreens Expands Clinical Trial Capabilities, Focusing on Diversity and Accessibility
Walgreens is leveraging its pharmacy network to enhance patient recruitment and real-world evidence services for biopharma, emphasizing improved access and representation in clinical trials.
FDA Grants Accelerated Approval to Zymeworks' Ziihera for HER2-Positive Biliary Tract Cancer
Zymeworks' Ziihera (zanidatamab) receives accelerated approval from the FDA for treating HER2-positive biliary tract cancer (BTC).
Regen BioPharma's HemaXellerate™ Phase 1 Trial Aims to Redefine Aplastic Anemia Treatment
Regen BioPharma is advancing HemaXellerate™, a stem cell-derived therapy, into a Phase 1 clinical trial following FDA clearance, initially targeting aplastic anemia.
Gravitas Medical's Entarik System Receives Second FDA Clearance for Neonatal Enteral Nutrition
Gravitas Medical's Entarik system has received its second FDA clearance, making it the only smart enteral nutrition delivery system for neonates.
BioAdaptives' Zeranovia Receives IRB Approval for Human Clinical Trial in Weight Management
BioAdaptives Inc. has secured Institutional Review Board (IRB) approval to commence a human clinical trial for its weight management product, Zeranovia™.
Protara's TARA-002 Shows Promise in Phase 2 Trial for Bladder Cancer
Protara Therapeutics' TARA-002 demonstrated a 72% six-month complete response rate in NMIBC patients across various BCG exposure statuses.
FDA Lifts Clinical Hold on Ocugen's OCU200 Phase 1 Trial for Diabetic Macular Edema
The FDA has removed the clinical hold on Ocugen's investigational new drug application for OCU200, a novel treatment for diabetic macular edema (DME).
INmune Bio Completes Enrollment in Phase 2 Alzheimer's Trial and Reports Positive NK-Cell Data in Prostate Cancer Study
INmune Bio completed enrollment for its Phase 2 Alzheimer’s Disease trial (AD02) focused on early AD patients with elevated neuroinflammation biomarkers.
Nanoscope Therapeutics Enhances Vision Restoration Therapy with CatCh Technology License
Nanoscope Therapeutics has licensed the CatCh technology from Max Planck Innovation to boost the light sensitivity of its MCO-010 gene therapy.
UNITY Biotechnology's UBX1325 Pivotal Trial Design for Diabetic Macular Edema
UNITY Biotechnology's UBX1325 (foselutoclax) is under development as a novel senolytic therapeutic for diabetic macular edema (DME).
Biofrontera Announces Database Lock for Phase 3 sBCC Study of Ameluz®-PDT
Biofrontera has locked the database for its Phase 3 trial evaluating Ameluz®-PDT for superficial basal cell carcinoma (sBCC) treatment.
PLT012 Receives FDA Orphan Drug Designation for Liver and Bile Duct Cancers
Pilatus Biosciences' PLT012 has been granted Orphan Drug Designation by the FDA for the treatment of liver and intrahepatic bile duct cancers (HCC/ICCA).
Acelyrin's Clinical Programs Advance with Robust Financial Backing
Acelyrin reported a strong cash position of $788.4 million, expected to fund operations through key clinical milestones in its autoimmune and inflammatory disease programs.
ME Therapeutics Advances Anti-G-CSF Antibody for Cancer Immunotherapy
ME Therapeutics is progressing its anti-G-CSF antibody candidate, h1B11-12, towards first-in-human clinical trials, with GMP production anticipated in the second half of 2025.
Immunic's Vidofludimus Calcium Advances in MS Trials; I-Mab's Immunotherapies Show Promise
Immunic's phase 3 ENSURE program for vidofludimus calcium in relapsing multiple sclerosis (RMS) continues as planned after a positive interim futility analysis.
Cassava Sciences Faces Class Action Lawsuit After Simufilam Fails Phase 3 Trial
A class action lawsuit has been filed against Cassava Sciences, alleging securities fraud related to its Alzheimer's drug candidate, simufilam.
CorMedix Announces Positive Preliminary Q4 2024 Results and Business Updates
CorMedix reported preliminary unaudited net revenue of approximately $31 million for Q4 2024 and $43 million for FY 2024, exceeding previous guidance.
Immunic's Vidofludimus Calcium Shows Promise in Multiple Sclerosis Trials
Immunic's Phase 3 ENSURE program for relapsing multiple sclerosis (RMS) continues as planned after a positive interim analysis by the Independent Data Monitoring Committee.
MAIA Biotechnology's THIO-101 Shows Promising Survival Data in Advanced NSCLC
MAIA Biotechnology's THIO-101, sequenced with cemiplimab, demonstrates encouraging efficacy in advanced non-small cell lung cancer (NSCLC) patients who have failed multiple prior therapies.