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🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
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LENZ Therapeutics Submits VIZZ Presbyopia Treatment for UK Approval Following EU Validation
LENZ Therapeutics submits VIZZ aceclidine eye drops to UK MHRA for presbyopia treatment approval, following successful EU regulatory validation in March 2026.
Pasithea Therapeutics' PAS-004 Receives FDA Rare Pediatric Disease Designation for Neurofibromatosis Type 1 Treatment
FDA grants Rare Pediatric Disease Designation to Pasithea's PAS-004, a next-generation MEK inhibitor for treating Neurofibromatosis Type 1 in children.
Clearmind Medicine CMND-100 Meets Primary Safety Endpoint in Alcohol Use Disorder Trial
Clearmind Medicine announces positive safety results for CMND-100, its non-hallucinogenic psychedelic treatment for alcohol use disorder in Phase 1 trial.
Sapience Therapeutics ST316 Shows 47% Response Rate in Phase 2 Colorectal Cancer Trial
ST316, a first-in-class β-catenin antagonist, demonstrated 47% objective response rate and 93% disease control in second-line colorectal cancer patients.
Tozorakimab Meets Primary Endpoint in Phase III COPD Trial, Shows Significant Reduction in Exacerbations
First-in-class tozorakimab demonstrates statistically significant reduction in COPD exacerbations across all patient populations in pivotal Phase III MIRANDA trial.
Abogen's ABO2203 mRNA Cancer Therapy Shows Promise in First-in-Human B-Cell Lymphoma Trial at AACR 2026
Abogen presents preliminary results of ABO2203, an innovative mRNA-encoded bispecific T-cell engager for relapsed/refractory B-cell lymphoma treatment.
Verismo Therapeutics SynKIR-110 Shows Promising Safety Profile in Phase 1 STAR-101 Trial for Advanced Solid Tumors
Verismo's SynKIR-110 KIR-CAR therapy demonstrates favorable safety and dose-dependent efficacy in Phase 1 trial for advanced solid tumors with no dose-limiting toxicities.
Inhibrx Biosciences to Present Ozekibart (INBRX-109) Clinical Data for Late-Line Colorectal Cancer Treatment
Inhibrx Biosciences will host a webcast on April 21, 2026, to share Phase 1/2 clinical trial results for ozekibart in late-line colorectal cancer patients.
Akeso's Cadonilimab Shows Promising Survival Benefit in Advanced Pancreatic Cancer Phase II Trial
Akeso's first-in-class PD-1/CTLA-4 bispecific antibody cadonilimab demonstrates survival benefit in advanced pancreatic cancer COMPASSION-26 trial.
Debiopharm's Lunresertib Receives FDA Fast Track Designation for Platinum-Resistant Ovarian Cancer Treatment
Debiopharm announces FDA Fast Track designation for Lunresertib combination therapy targeting genomic-defined platinum-resistant ovarian cancer patients.
Adcendo ApS Advances ADCE-T02 Antibody-Drug Conjugate to Expansion Phase, ADCE-D01 Receives FDA Orphan Drug Status
Adcendo ApS reports pipeline progress with ADCE-T02 entering cohort expansion in solid tumors and ADCE-D01 receiving FDA Orphan Drug Designation for cancer treatment.
FDA Accepts Genentech's Gazyva Application for Systemic Lupus Erythematosus Treatment
FDA accepts Genentech's supplemental application for Gazyva (obinutuzumab) to treat systemic lupus erythematosus based on positive Phase III results.
FDA Grants Priority Review to PADCEV-Keytruda Combination for Muscle-Invasive Bladder Cancer Treatment
Astellas receives FDA Priority Review for PADCEV plus Keytruda as first perioperative treatment for muscle-invasive bladder cancer regardless of cisplatin eligibility.
FDA Approves DermaClear: New Safe Option for Severe Acne Vulgaris
The FDA has approved DermaClear, a groundbreaking treatment for severe acne vulgaris, providing patients with a safe and effective solution for clearer skin.
FDA Approves First Cell Therapy for Treatment-Resistant MS
The FDA has approved AHSCT, the first cell therapy for treatment-resistant multiple sclerosis, marking a significant advancement in MS treatment options.
FDA Biosimilar Substitution Policy Update: Key Regulatory Changes
The FDA's recent biosimilar substitution policy update introduces significant regulatory changes affecting Humira's use in rheumatoid arthritis treatment.
FDA Approves Paxlovid: Key Details on Pfizer's COVID-19 Treatment EUA
The FDA has granted Emergency Use Authorization for Paxlovid, Pfizer's antiviral treatment for COVID-19, marking a significant advancement in pandemic response.
FDA Approves Riabni Biosimilar: Expanding NHL Treatment Options
The FDA's approval of Riabni as a biosimilar for non-Hodgkin lymphoma (NHL) marks a significant advancement in treatment options for patients.
FDA Approval Adagrasib: Accelerated OK for KRAS G12C NSCLC Treatment
Adagrasib receives FDA accelerated approval for KRAS G12C NSCLC, marking a significant advancement in targeted lung cancer treatment options.
FDA Approves Apretude: First Injectable PrEP for HIV Prevention
Apretude has been approved by the FDA as the first injectable PrEP for HIV prevention, providing a groundbreaking option for those at risk of infection.