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Veradermics VDPHL01 Phase 2/3 Trial Results for Male Pattern Hair Loss to Be Announced
Veradermics announces investor call to discuss topline results from Phase 2/3 study of VDPHL01 for mild-to-moderate male pattern hair loss treatment.
Veradermics VDPHL01 Phase 2/3 Trial Results: Conference Call Scheduled for Oral Minoxidil Hair Loss Treatment
Veradermics announces investor call to discuss Phase 2/3 trial results for VDPHL01, an extended-release oral minoxidil tablet for male pattern hair loss.
Adagio Medical's vCLAS Ventricular Ablation System Shows 84% Success Rate in Pivotal Trial for Heart Arrhythmia Treatment
Adagio Medical's vCLAS system achieved 84% freedom from shock and 59% freedom from VT recurrence in FULCRUM-VT pivotal trial, meeting primary endpoints.
Pharma Compliance Congress 2026 Opens: Key Regulatory Themes
The Pharmaceutical Compliance Congress 2026 opened in McLean, USA, focusing on compliance amid increasing regulatory oversight. No immediate updates are available as the event begins.
ACRP 2026: Immunology Updates and Clinical Trial Insights
ACRP 2026 represents a key clinical research conference, though specific immunology clinical trial data and presentations have not yet been released through official channels. NovaPharmaNews will update coverage as verified proceedings become available.
Atara Biotherapeutics Faces Securities Class Action Lawsuit with May 2026 Deadline for Lead Plaintiff Applications
Atara Biotherapeutics investors with losses exceeding $100K can join securities class action lawsuit. Lead plaintiff deadline set for May 22, 2026.
Aquestive Therapeutics Faces Class Action Lawsuit Over Alleged FDA Application Misrepresentations
Aquestive Therapeutics investors who purchased AQST stock between June 2025 and January 2026 face May 4 deadline to join class action lawsuit over alleged FDA misstatements.
Pulse Biosciences nPulse Cardiac Catheter Shows High Durability in Heart Rhythm 2026 Trial Data
Pulse Biosciences presents positive multicenter trial results for nPulse cardiac catheter system, showing sustained durability for atrial fibrillation treatment.
Abbott TactiFlex Duo Ablation Catheter Shows Positive Results for Complex AFib Treatment at Heart Rhythm Society 2026
Abbott presents positive 6-month FlexPulse IDE study results for TactiFlex Duo Ablation Catheter treating complex atrial fibrillation at Heart Rhythm Society 2026.
Medtronic Affera Sphere-9 Catheter Receives FDA Breakthrough Device Designation for Ventricular Tachycardia Treatment
Medtronic's Sphere-9 catheter gains FDA breakthrough status for VT treatment while Sphere-360 shows consistent durability across patient anatomies in new clinical data.
FDA Generic Drug User Fee Amendments (GDUFA) Program Updates Fee Structure and Payment Methods for 2024
FDA updates Generic Drug User Fee Amendments program with new fee structures and payment methods, impacting generic drug manufacturers and approval timelines.
FDA Proposes OMUFA User Fee Program for Over-the-Counter Monograph Drugs to Supplement Congressional Funding
FDA introduces OMUFA user fee program for OTC monograph drugs as potential funding mechanism to supplement congressional appropriations for regulatory oversight.
FDA Begins Preparation for GDUFA IV Reauthorization: Generic Drug User Fee Program 2028-2032
FDA initiates preparation for GDUFA IV reauthorization covering fiscal years 2028-2032, setting stage for next phase of generic drug user fee program.
FDA Encourages Testosterone Therapy Expansion for Low Libido in Men with Hypogonadism
FDA takes initial step to advance testosterone replacement therapy for low libido in men with idiopathic hypogonadism, encouraging sponsors to pursue new indication.
FDA Achieves Year 1 Goals in Reducing Animal Testing for Drug Development Through Alternative Methods
FDA successfully launches key initiatives to replace animal testing with alternative methods in drug development, achieving first-year roadmap goals.
CMS and FDA Launch RAPID Coverage Pathway for Breakthrough Medical Devices Under Medicare
CMS and FDA announce RAPID coverage pathway to accelerate Medicare access to breakthrough medical devices, reducing coverage review delays for patients.
FDA Approves Otarmeni: First Gene Therapy for Genetic Hearing Loss Under Priority Voucher Program
FDA approves Otarmeni (lunsotogene parvec-cwha), the first dual AAV vector gene therapy for genetic hearing loss under National Priority Voucher Program.
FDA Accelerates Mental Health Treatment Access Following Presidential Executive Order on Serious Mental Illness
FDA implements new measures to expedite access to treatments for serious mental illness, including treatment-resistant conditions, following April 18 Executive Order.
ACRP 2026: Immunology Updates - Day 1 Key Takeaways
ACRP 2026 Day 1 did not feature major immunology clinical trial readouts, though the conference provides a platform for clinical research professionals to discuss emerging trends in trial design and patient engagement relevant to immunology research programs.
SCOPE X 2026: Clinical Ops, Data, and AI in Boston
SCOPE X 2026, organized by IQVIA, will focus on clinical operations, data services, and AI in Boston in May 2026. The event will address industry challenges and advancements in clinical trial processes.