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HHS Approves Mandatory Fentanyl Testing for Truck Drivers Starting July 2024

1/30/2025

The U.S. Department of Health and Human Services has authorized testing for fentanyl in federally regulated occupations, including truck drivers, through both urine and oral fluid drug panels effective July 2024.

Oncology Leaders Highlight Growing Challenges in Managing Cancer Treatment Data

12/18/2024

Leading oncology CMOs express concern over the overwhelming volume of practice-changing data emerging from major conferences, making it increasingly difficult for physicians to stay current with optimal treatment approaches.

Study Links Moderately High Calcium Intake to Increased Eczema Risk in Specific Populations

1/14/2025

A cross-sectional study of 4,086 adults reveals that moderately high dietary calcium intake (770-1151.5 mg) is associated with increased eczema prevalence, particularly affecting postmenopausal women and non-Hispanic White individuals.

FDA Grants Historic Marketing Authorization for Zyn Nicotine Pouches Despite Youth Usage Concerns

1/16/2025

The FDA has authorized marketing of 20 Zyn nicotine pouch products, marking the first-ever approval in this category after extensive scientific review showing lower health risks compared to traditional tobacco products.

Increased Antimicrobial Use Precedes B-Cell Cancer Diagnosis by Up to a Decade, Danish Study Reveals

9/13/2024

A comprehensive Danish study of over 48,000 patients reveals significantly elevated antimicrobial use in multiple B-cell cancer types, particularly CLL, MM, MZL, and LPL, up to 10 years before diagnosis.

Capivasertib Shows Promise in ER+/HER2- Metastatic Breast Cancer with PIK3CA Mutations

9/21/2024

Capivasertib combined with fulvestrant demonstrates significant progression-free survival benefit in patients with AKT pathway-altered metastatic breast cancer, showing a median PFS of 7.3 months versus 3.1 months with placebo.

LAM561 Shows Promising PFS Data in MGMT-Methylated Glioblastoma Patients

3/5/2025

Laminar Pharma's LAM561, combined with standard chemoradiotherapy, demonstrates significant progression-free survival improvement in MGMT-methylated glioblastoma patients, with PFS extending to 86.4 weeks versus 54.7 weeks in the placebo group.

Global Lung Ambition Alliance Takes Aim at Three Major Challenges in Lung Cancer Care

1/20/2020

The Lung Ambition Alliance, a partnership of major healthcare organizations, aims to double five-year lung cancer survival rates by 2025 through improved screening, innovative medicines, and enhanced quality of care.

FDA Clears Pi-Cardia's ShortCut Device for Valve-in-Valve TAVR Procedures

9/30/2024

Pi-Cardia's ShortCut device receives FDA clearance to reduce coronary obstruction risk during valve-in-valve transcatheter aortic valve replacement (TAVR).

Sonrotoclax Plus Dexamethasone Shows Promise in Relapsed/Refractory Multiple Myeloma

9/30/2024

The combination of sonrotoclax and dexamethasone demonstrated a 75% overall response rate in heavily pretreated patients with relapsed/refractory multiple myeloma.

Toleranzia Submits Clinical Trial Application for TOL2 in Myasthenia Gravis

10/2/2024

Toleranzia has submitted a clinical trial application (CTA) for TOL2, a drug candidate targeting the underlying cause of myasthenia gravis.

PDS Biotech's PDS0101 Shows Promising Survival Data in Advanced Cervical Cancer Trial

10/3/2024

PDS Biotechnology's IMMUNOCERV trial shows an 84.4% overall survival rate at 36 months for advanced cervical cancer patients treated with PDS0101 and chemoradiation.

Elucid's AI-Powered PlaqueIQ Receives FDA Clearance for Cardiovascular Risk Assessment

10/3/2024

Elucid's PlaqueIQ, an AI-driven image analysis software, has secured FDA 510(k) clearance for detecting arterial plaque, a key indicator of cardiovascular disease (CVD).

Sun Pharma Receives CDSCO Panel Nod for Aflibercept Phase III Study in Wet AMD

10/6/2024

Sun Pharmaceutical Industries has received approval from the CDSCO panel to conduct a Phase III clinical trial of Aflibercept injection for neovascular age-related macular degeneration.

Rhythm Biosciences' ColoSTAT 2.0 Shows Improved Performance in Colorectal Cancer Detection

10/7/2024

Rhythm Biosciences' second-generation ColoSTAT kit demonstrated superior analytical results compared to its predecessor in preliminary testing using 200 patient serum samples.

Alzheimer's Drugs May Pose Safety Concerns for Down Syndrome Patients

10/8/2024

Post-mortem brain tissue study reveals anti-amyloid Alzheimer's drugs extensively bind to blood vessels in individuals with Down syndrome, raising safety concerns.

uniQure's AMT-130 Shows Promise in Huntington's Disease, FDA Meeting Scheduled

11/6/2024

uniQure's AMT-130 demonstrated a statistically significant, dose-dependent slowing of Huntington's disease progression in Phase I/II trials, as measured by the cUHDRS.

Ionis Pharmaceuticals Advances Pipeline with Key Regulatory and Clinical Milestones

11/6/2024

Ionis Pharmaceuticals reports positive progress with WAINUA launch and regulatory approvals in the UK and Europe for ATTRv-PN treatment.

Soleno Therapeutics' DCCR for Prader-Willi Syndrome Receives Priority Review from FDA

11/6/2024

Soleno Therapeutics' New Drug Application (NDA) for DCCR (diazoxide choline) for Prader-Willi syndrome (PWS) has been accepted by the FDA and granted Priority Review.

Adicet Bio Expands ADI-001 Trial for Autoimmune Diseases, Reports Q3 2024 Results

11/6/2024

Adicet Bio broadens its ADI-001 Phase 1 trial to include six autoimmune indications, with preliminary lupus nephritis data anticipated in the first half of 2025.

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