Articles by Michael Rivera
InflaRx Reports Favorable Safety Profile for Izicopan in Liver Metabolism Study
InflaRx announces positive pre-clinical data showing low reactive metabolite formation for izicopan in human liver microsomes, supporting drug safety profile.
FDA Approves Guardant360 CDx as Companion Diagnostic for Pfizer's VEPPANU in ER+/HER2- Breast Cancer
Guardant Health receives FDA approval for Guardant360 CDx liquid biopsy test as companion diagnostic for VEPPANU (vepdegestrant) in advanced breast cancer patients.
ZETA SURGICAL Receives FDA 510(k) Clearance for Brain Surgery Navigation System
ZETA SURGICAL's Zeta Navigation System receives FDA 510(k) clearance for brain tumor biopsies, hydrocephalus treatment, and trigeminal neuralgia procedures.
Arvinas Receives FDA Approval for VEPPANU (Vepdegestrant), First PROTAC Drug for ESR1-Mutated Breast Cancer
Arvinas announces FDA approval of VEPPANU, the first PROTAC protein degrader for ESR1-mutated, ER+/HER2- advanced breast cancer treatment.
FDA Places Clinical Hold on Newron's Evenamide Phase III Trial for Treatment-Resistant Schizophrenia
FDA halts enrollment in Newron's Phase III ENIGMA-TRS 2 study of evenamide for treatment-resistant schizophrenia, creating regulatory uncertainty for the novel therapy.
Tempest Therapeutics TPST-2003 CAR-T Shows Promise for Multiple Myeloma at ISCT 2026
Tempest Therapeutics presents positive TPST-2003 dual-targeting CAR-T data for relapsed/refractory multiple myeloma patients at ISCT 2026 meeting.
EMA Accelerated Assessment Biologics: Market Uptake Forecast in EU
This article analyzes the EMA's accelerated assessment process for biologics, focusing on XYZ Drug for cancer and its projected market uptake in the EU.
Digital Health Integration in MEA Clinical Trials: Current State & Future Outlook
This article delves into the integration of digital health technologies in MEA clinical trials, focusing on their impact on drug development and patient outcomes.
Clinical Trial Result Reporting Compliance in MEA: Global Registry Analysis
This article delves into the compliance of clinical trial result reporting for drug XYZ in the MEA region, highlighting insights from a global registry analysis.
Aclaris Therapeutics ATI-052 Shows Promising 45-Day Half-Life in Phase 1a Trial Results
Aclaris Therapeutics announces positive Phase 1a results for ATI-052, a first-in-class anti-TSLP/IL-4Rα bispecific antibody with 45-day half-life for Th2 diseases.
C-Ray Therapeutics Receives FDA Acceptance for Copper-64 Drug Master File, Advancing Radiopharmaceutical Development
C-Ray Therapeutics' Copper-64 Drug Master File receives FDA acceptance, enabling global radiopharmaceutical developers to reference DMF No. 43568 for submissions.
AbbVie Submits FDA Application for Upadacitinib (RINVOQ) to Treat Severe Alopecia Areata
AbbVie submits FDA application for upadacitinib (RINVOQ) to treat severe alopecia areata in adults and adolescents, backed by Phase 3 trial data.
Novartis Reports Strong Q1 2026 Growth Led by Remibrutinib CHMP Approval and Pipeline Advances
Novartis delivers strong Q1 2026 growth with Remibrutinib receiving positive CHMP opinion for chronic spontaneous urticaria and multiple pipeline milestones.
DMX-200 ACTION3 Trial Maintains Statistical Power Above 90% Following Blinded Data Review
External statistical review confirms DMX-200's ACTION3 trial remains >90% powered to demonstrate proteinuria reduction in kidney disease patients.
FDA Grants Priority Review for IMAAVY (Nipocalimab-aahu) as First Potential Treatment for Warm Autoimmune Hemolytic Anemia
FDA grants Priority Review for IMAAVY (nipocalimab-aahu), potentially the first approved treatment for warm autoimmune hemolytic anemia (wAIHA).
Merck Mayo Clinic AI Partnership: Advancing Drug Discovery
Merck and the Mayo Clinic have joined forces to leverage AI in accelerating drug discovery and development. This partnership combines Merck's expertise with Mayo Clinic's research capabilities to transform pharmaceutical innovation.
Sun Pharma Acquires Organon for $11.75 Billion in Major Pharmaceutical Merger
Sun Pharmaceutical Industries announces $11.75 billion acquisition of Organon at $14 per share, creating global pharmaceutical powerhouse.
Boston Scientific FARAPULSE and WATCHMAN Show Positive Safety Data at Heart Rhythm 2026
Boston Scientific presents positive clinical trial data for FARAPULSE Pulsed Field Ablation and WATCHMAN devices at Heart Rhythm 2026 conference.
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.