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🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates.
Breaking Arvinas VEPPANU (Vepdegestrant) Receives FDA Approval as First PROTAC Drug for ESR1-Mutated Breast Cancer
Arvinas' VEPPANU becomes the first FDA-approved PROTAC drug for ESR1-mutated, ER+/HER2- advanced breast cancer, marking a breakthrough in protein degradation therapy.
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Palvella Therapeutics Begins Phase 2 Trial of QTORIN Rapamycin for Rare Angiokeratomas
Palvella Therapeutics doses first patients in Phase 2 LOTU trial of QTORIN rapamycin for angiokeratomas, targeting over 50,000 US patients with no approved treatments.
Neurocrine Biosciences Begins Phase 1 Trial of NBIP-2118 for Obesity Treatment
Neurocrine Biosciences initiates first-in-human Phase 1 trial for NBIP-2118, a novel CRF2 receptor agonist targeting obesity through non-incretin mechanisms.
CAPLYTA (Lumateperone) Ranks Highest Among FDA-Approved Adjunctive Depression Treatments in Network Meta-Analysis
New network meta-analysis shows CAPLYTA demonstrated superior efficacy across four key measures compared to other FDA-approved adjunctive MDD therapies.
Cellenkos Receives FDA Clearance for CK0802 Phase 2a Trial in Steroid-Refractory GVHD
Cellenkos gets FDA approval to test CK0802, a first-in-class regulatory T cell therapy for patients with steroid-refractory graft-versus-host disease.
Cellenkos Receives FDA Clearance for CK0802 Phase 1b/2a Trial in Steroid-Refractory GVHD
Cellenkos gets FDA clearance for CK0802 Phase 1b/2a trial targeting steroid-refractory graft-versus-host disease with first-in-class Treg therapy.
FDA Approves Guardant360 CDx Companion Diagnostic for Pfizer's VEPPANU in ER+/HER2- Breast Cancer
Guardant Health receives FDA approval for blood-based companion diagnostic to identify patients eligible for VEPPANU treatment in advanced breast cancer with ESR1 mutations.
Opus Genetics' OPGx-LCA5 Gene Therapy Accepted Into FDA's Rare Disease Evidence Program
Opus Genetics announces FDA acceptance of OPGx-LCA5 gene therapy into RDEP program, advancing treatment for inherited retinal disease LCA5.
Clene Receives FDA Green Light for CNM-Au8 Accelerated Approval Pathway in ALS Treatment
Clene advances CNM-Au8 for ALS treatment after FDA confirms accelerated approval pathway eligibility based on neurofilament light biomarker data.
Alpha Tau's Alpha DaRT Achieves 100% Local Disease Control in Pancreatic Cancer Trials at DDW 2026
Alpha Tau reports 100% local disease control with Alpha DaRT in pancreatic cancer trials, showing favorable safety profile in 26 patients at DDW 2026.
Takeda's TAK-881 Shows Positive Phase 2/3 Results for Primary Immunodeficiency Disease Treatment
Takeda announces positive topline results for TAK-881 in pivotal Phase 2/3 trial, showing comparable efficacy to HYQVIA with reduced infusion time for PID patients.
Accord Healthcare Relaunches Tadalafil Tablets in Multiple Dosage Strengths, Expanding Generic ED Treatment Access
Accord Healthcare announces relaunch of FDA-approved generic tadalafil tablets in multiple strengths, improving affordable access to ED treatment options.
InspireMD Receives FDA Approval for SwitchGuard Neuro Protection System CGUARDIANS III Pivotal Trial
InspireMD secures FDA IDE approval for CGUARDIANS III pivotal study of SwitchGuard Neuro Protection System, advancing stroke prevention technology development.
CRISPR Therapeutics' CASGEVY Reaches 60,000+ Eligible Patients Across 10 Countries Following Global Approvals
CRISPR Therapeutics reports CASGEVY now approved in 10 countries for severe sickle cell disease and beta thalassemia, reaching over 60,000 eligible patients worldwide.
Clene's CNM-Au8 Gets FDA Green Light for Accelerated Approval Pathway in ALS Treatment
FDA confirms Clene's CNM-Au8 ALS drug can proceed via accelerated approval pathway using neurofilament light biomarker data, with NDA filing expected Q3 2026.
Atossa Therapeutics Receives FDA Rare Pediatric Disease Designation for (Z)-Endoxifen in McCune-Albright Syndrome
Atossa Therapeutics gains FDA Rare Pediatric Disease designation for (Z)-endoxifen treating McCune-Albright syndrome, qualifying for Priority Review Voucher.
mBIOTA Elemental Diet Shows Promise for IBS Treatment in New Clinical Trial Data Presented at DDW 2026
New clinical trial data validates mBIOTA Elemental as effective IBS therapeutic, showing symptom improvement across all three IBS subtypes at DDW 2026.
Novartis Receives Health Canada Approval for Fabhalta Oral Treatment for C3G Patients
Health Canada approves Novartis' Fabhalta (iptacopan) oral treatment for adults with complement 3 glomerulopathy, offering new hope for rare kidney disease patients.
ASCO 2026: Cellectar's Waldenström Macroglobulinemia Data
Cellectar Biosciences will present CLOVER WaM (iopofosine I 131) data at ASCO 2026, focusing on efficacy subset data in relapsed/refractory Waldenström macroglobulinemia.
Alpha Tau's Alpha DaRT Achieves 100% Local Disease Control in Pancreatic Cancer Trials at DDW 2026
Alpha Tau reports 100% local disease control with Alpha DaRT device in heavily pre-treated pancreatic cancer patients with favorable safety profile.
Cytokinetics to Report Aficamten Phase 3 Trial Results for Non-Obstructive Hypertrophic Cardiomyopathy May 5, 2026
Cytokinetics announces topline results from pivotal ACACIA-HCM Phase 3 trial of aficamten for non-obstructive hypertrophic cardiomyopathy on May 5, 2026.