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🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
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Mabwell's LILRB4/CD3 Bispecific Antibody 6MW5311 Receives NMPA IND Approval for Leukemia Treatment
Mabwell's innovative LILRB4/CD3 bispecific antibody 6MW5311 gets NMPA IND acceptance for AML and CMML treatment, marking a significant oncology milestone.
Mabwell's MAIWEIJIAN Denosumab Gets NMPA Acceptance for Expanded Cancer Bone Treatment
China's NMPA accepts Mabwell's supplemental application for MAIWEIJIAN denosumab to prevent bone complications in multiple myeloma and solid tumor patients.
ThinkTrends AI Platform Deployed by Federal Health Agency for Nationwide Adverse Event Monitoring System
ThinkTrends agentic AI platform goes live with U.S. Federal Health Agency's new Adverse Event Monitoring System to improve drug and medical device safety tracking.
Fullscript Journeys Launches Digital Health Platform for 125,000 Healthcare Providers
Fullscript launches Journeys platform, empowering 125,000 healthcare providers with consumer-grade digital health experiences for 5 million patients.
Nexalin Technology Advances FDA Strategy for Alzheimer's Treatment Following U.S. and China Leadership Meetings
Nexalin Technology completes strategic meetings in U.S. and China to advance FDA clinical strategy for Alzheimer's treatment using DIFS brain stimulation technology.
ImmunityBio (IBRX) Faces FDA Warning Letter and Class Action Lawsuit Over Ankt Drug Claims
ImmunityBio faces securities lawsuit after FDA warning letter regarding executive claims about lead biologic Ankt, affecting investors from Jan-Mar 2026.
FDA Warning Letters: Understanding Pharmaceutical Compliance Actions and Their Impact on Drug Safety
FDA warning letters serve as critical regulatory tools for pharmaceutical compliance. Learn how these enforcement actions impact drug safety and market access.
GSK's Depemokimab Receives European and Chinese Approvals, Expanding Global Access to Ultra-Long-Acting Biologic
GSK's depemokimab gains regulatory approval from European Commission and China's NMPA, adding to existing approvals in US, Japan, and UK markets.
Elion Therapeutics Launches Phase 2 Trial for Turletricin (EL219) in Invasive Mold Infections
Elion Therapeutics initiates Phase 2 clinical trial for turletricin (EL219) targeting invasive mold infections, with FDA Fast Track and QIDP designations.
Glaukos Receives Permanent J-Code J2789 for Epioxa™ Ophthalmic Treatment, Effective July 2026
Glaukos Corporation secures permanent HCPCS J-code J2789 for Epioxa™ from CMS, streamlining Medicare reimbursement for ophthalmic treatments starting July 2026.
Nkarta Receives FDA Approval for Outpatient NKX019 Dosing in Autoimmune Disease Treatment
Nkarta secures FDA agreement for outpatient NKX019 dosing, expanding access to community rheumatology centers and reducing patient treatment burden.
Dogwood Therapeutics SP16 Gets FDA IND Approval for Chemotherapy-Induced Pain Treatment
Dogwood Therapeutics receives FDA IND acceptance for SP16, a non-opioid IV treatment targeting chemotherapy-induced pain and neuropathy in cancer patients.
PDS Biotech's PDS01ADC Shows 78% Response Rate in Metastatic Colorectal Cancer Phase 2 Trial
PDS01ADC demonstrates 78% objective response rate vs 35% control in microsatellite stable metastatic colorectal cancer, offering hope for difficult-to-treat patients.
Neffy Epinephrine Nasal Spray Approved in Canada as First Needle-Free Anaphylaxis Treatment by ARS Pharmaceuticals
Health Canada approves neffy® nasal spray, the first needle-free epinephrine treatment for anaphylaxis in adults and children over 30kg, available summer 2026.
Cala Receives FDA Clearance for Next-Generation kIQ Plus Wearable Device for Essential Tremor and Parkinson's Disease
Cala announces FDA clearance for its advanced kIQ Plus wearable neurostimulation device, featuring enhanced TAPS therapy for tremor management.
FDA Approves RAPIBLYK (Landiolol) for Pediatric Supraventricular Tachycardia - AOP Health US Expands Critical Care Treatment Options
FDA approves RAPIBLYK (landiolol) by AOP Health US for pediatric patients with supraventricular tachycardia, expanding critical care treatment options.
ASCO 2026: GI Innovation's GI-101A Phase 1 Data Preview
GI Innovation will present Phase 1 clinical data on GI-101A at ASCO 2026, highlighting its potential in solid tumors. The presentation will focus on efficacy, safety, and combination therapy strategies.
FDA Approves SleepWell: New Non-Habit Forming Treatment for Chronic Insomnia
The FDA has approved SleepWell, a groundbreaking non-habit forming treatment for chronic insomnia, promising to improve sleep quality without the risk of addiction.
FDA Approval NanoPharm Therapy: Accelerated OK for Metastatic Breast Cancer
The FDA has granted accelerated approval for NanoPharm Therapy, a groundbreaking treatment for metastatic breast cancer, paving the way for innovative patient care.
FDA Approves FluGuard+ Vaccine: Enhanced Protection Against Emerging Flu
The FDA has approved FluGuard+, a new vaccine designed to provide enhanced protection against emerging flu strains, improving public health outcomes.