News
🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
Latest News
OCT East Coast 2026: Clinical Trial Innovation & Outsourcing
OCT East Coast 2026 conference, held May 13-14, 2026, in New Brunswick, New Jersey, focuses on clinical operations, outsourcing, clinical technology, and innovation. Key discussions will cover trial resilience, outsourcing models, patient recruitment, and AI in clinical trials.
Frankfurt Court Upholds BESREMi Arbitral Award Favoring AOP Health Over PharmaEssentia
Frankfurt Higher Regional Court confirms ICC arbitral award in favor of AOP Health against PharmaEssentia Corp regarding BESREMi dispute damages.
Novartis Coartem Baby Receives WHO Prequalification as First Malaria Treatment for Newborns
WHO prequalifies Novartis Coartem Baby, the first malaria treatment for newborns and young infants, enabling global procurement and access.
Miracell's SMART M-CELL Stem Cell Therapy Shows Cognitive Improvement in Severe Alzheimer's Patients
Miracell reports positive Phase 2 results for SMART M-CELL CD34+ stem cell therapy showing cognitive improvement in moderate to severe Alzheimer's patients.
Berlin Heals Reports Positive First-in-Human Results for Less Invasive Heart Failure Device in CMIC-III Study
Berlin Heals announces positive CMIC-III first-in-human study results showing improved heart function and quality of life with less invasive heart failure device.
Citius Pharmaceuticals Raises $5 Million Through Direct Stock Offering at $0.985 Per Share
Citius Pharmaceuticals announces $5M registered direct offering of 5.08M shares at $0.985 each to fund critical care drug development programs.
Haemonetics VASCADE MVP XL Shows Superior Safety Profile in Large-Bore Venous Closure Study
New study demonstrates Haemonetics' VASCADE MVP XL vascular closure system's enhanced safety and efficacy in large-bore venous access procedures.
BrioHealth Solutions Receives FDA Conditional Approval for Pediatric BrioVAD Heart Device Trial
BrioHealth Solutions gets FDA conditional approval to test BrioVAD System in children with advanced heart failure through the Brio4Kids Trial study.
CGBIO Receives FDA 510(k) Clearance for EASYMADE TI Patient-Specific Titanium Implant
CGBIO becomes first Korean company to receive FDA 510(k) clearance for patient-specific titanium implant EASYMADE TI, marking regulatory milestone.
Cerapedics Secures Vizient Supplier Agreement for PearlMatrix P-15 Bone Graft Treatment
Cerapedics partners with Vizient to expand access to PearlMatrix P-15 Peptide Enhanced Bone Graft for lumbar spine degenerative disc disease treatment.
ACRP 2026: Immunology Clinical Research Highlights - Day 1
ACRP 2026 convenes clinical research professionals to discuss advances in immunology trials, including adaptive designs, biomarker-driven patient stratification, and emerging regulatory pathways for immunotherapy development. Detailed Day 1 immunology session data remains pending official conference release.
ACRP 2026: Immunology Updates and Clinical Research Trends
ACRP 2026 Annual Meeting convenes clinical research professionals and immunology specialists; specific immunology data presentations and clinical trial results are pending official release through ACRP's conference proceedings and affiliated scientific channels.
ACRP 2026: Immunology Updates and Clinical Research Trends
ACRP 2026 Annual Conference convenes clinical research and regulatory affairs professionals to discuss emerging immunology research trends, clinical trial innovations, and career opportunities in immunological drug development.
CorTec's Brain Interchange™ BCI System Accepted into FDA Total Product Life Cycle Advisory Program for Stroke Rehabilitation
CorTec GmbH receives FDA TAP enrollment for Brain Interchange™ BCI system, joining elite group with both Breakthrough Device Designation and TAP recognition.
Tivic Health Rebrands as Valion Bio, Advances Entolimod for Acute Radiation Syndrome with FDA Fast Track Status
Tivic Health Systems rebrands as Valion Bio, advancing Entolimod for Acute Radiation Syndrome with FDA Fast Track and Orphan Drug designations.
Edwards Lifesciences Raises 2026 Guidance After Strong Q1 TMTT Sales Hit $173 Million
Edwards Lifesciences reported Q1 2026 TMTT sales of $173M and raised full-year guidance, with constant currency sales growth increased to 9-11%.
ImmunityBio (IBRX) Faces FDA Warning Letter and Class Action Lawsuit Over Anktiva Claims
ImmunityBio faces securities lawsuit after FDA warning letter regarding executive claims about lead immunotherapy drug Anktiva, impacting investor confidence.
TransMedics Unveils New CHOPS Organ Preservation System at ISHLT 2026 Meeting
TransMedics introduces Controlled Hypothermic Organ Preservation System (CHOPS) to expand portfolio and support clinical trials for heart and lung transplants.
AbbVie Receives FDA Complete Response Letter for TrenibotulinumtoxinE (TrenibotE) Manufacturing Issues
AbbVie's TrenibotulinumtoxinE faces FDA manufacturing concerns in Complete Response Letter, but no additional clinical studies required for approval.
Alpha Tau Receives FDA Approval to Expand Alpha DaRT Pancreatic Cancer Trial with Gemcitabine-Abraxane Combination
Alpha Tau's Alpha DaRT IMPACT trial expands to include gemcitabine-Abraxane chemotherapy combination for pancreatic cancer patients, increasing trial size to 40.