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🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
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FDA Approves Verapamil: Cardio-Med’s Extended-Release Formulation for Hypertension
The FDA has approved Cardio-Med’s extended-release formulation of Verapamil, offering a new option for managing hypertension effectively.
FDA Approves IMGN-901: Breakthrough Therapy for Relapsed/Refractory AML
The FDA has granted approval for IMGN-901, marking a significant advancement in treatment options for patients with relapsed or refractory acute myeloid leukemia (AML).
FDA Approves Revitan Gene Therapy for SMA Type 3: Key Details
The FDA has granted approval for Revitan, a groundbreaking gene therapy for SMA Type 3, promising significant advancements in treatment options for affected patients.
FDA Approval Mito-X: Accelerated Approval for Advanced Mitochondrial Disease
The FDA has granted accelerated approval for Mito-X, a groundbreaking treatment for advanced mitochondrial disease, marking a significant advancement in patient care.
FDA Approves Xylocor: Novel Therapy for Refractory Angina
Xylocor has received FDA approval as a groundbreaking treatment for refractory angina, providing a new option for patients suffering from chronic chest pain.
MAIA Biotechnology Activates First U.S. Site for Phase 2 Telomere-Targeting NSCLC Treatment Trial
MAIA Biotechnology launches first U.S. site for international Phase 2 trial of novel telomere-targeting therapy for advanced non-small cell lung cancer.
Dr. Falk Pharma and Renexxion Announce Naronapride Phase 2b Gastroparesis Results at DDW 2026
Dr. Falk Pharma and Renexxion present Phase 2b MOVE-IT study results for naronapride in gastroparesis treatment at Digestive Disease Week 2026.
Lilly's Foundayo Shows 57% Mortality Reduction in Landmark ACHIEVE-4 Diabetes Trial
Eli Lilly's Foundayo (orforglipron) demonstrates superior cardiovascular outcomes with 57% lower all-cause death risk vs insulin glargine in Phase 3 trial.
Aicuris Receives FDA Priority Review for Pritelivir, Novel Herpes Treatment for Immunocompromised Patients
FDA grants Priority Review for Aicuris' pritelivir NDA, targeting resistant herpes infections in immunocompromised patients with Q4 2026 PDUFA date.
Medera's AAV-SERCA2a Gene Therapy Receives FDA Fast Track Designation for Duchenne Muscular Dystrophy Cardiomyopathy
Medera Inc. receives FDA Fast Track designation for AAV-SERCA2a gene therapy targeting cardiomyopathy in Duchenne muscular dystrophy patients.
Boehringer Ingelheim's Zongertinib Shows Promise for HER2-Mutant Lung Cancer in NEJM Study
Boehringer Ingelheim's zongertinib demonstrates efficacy in HER2-mutant NSCLC patients, with Phase 1b Beamion LUNG-1 results published in NEJM following FDA approval.
FDA Approves MindBalance: First Digital Therapeutic for Anxiety, Depression
MindBalance has received FDA approval as the first digital therapeutic designed to treat anxiety and depression, marking a significant advancement in mental health care.
FDA Approves CancerVax for Adjuvant Melanoma Immunotherapy
The FDA has granted approval for CancerVax, a groundbreaking immunotherapy for adjuvant melanoma treatment, enhancing patient outcomes in skin cancer care.
FDA Approves PainBlock Patch: Novel Delivery System for Chronic Pain
The FDA has approved the PainBlock Patch, a groundbreaking delivery system designed to provide effective relief for chronic pain sufferers.
FDA Approves RenalProtect for Diabetic Kidney Disease Treatment
RenalProtect has received FDA approval for treating diabetic kidney disease, marking a significant advancement in patient care and management options.
FDA Approves LungRx Inhaled Therapy: Breakthrough for Pulmonary Hypertension
The FDA has granted approval for LungRx, an inhaled therapy that offers a groundbreaking treatment for pulmonary hypertension, enhancing patient care and outcomes.
FDA Updates Food Additive and Contact Substance Regulatory Timelines Through 2026
FDA releases updated timelines for food additive regulations, contact substance notifications, and color additive reviews extending through 2026.
Re:Cognition Health Launches International Clinical Trial for Revolutionary Finger-Prick Alzheimer's Blood Test
Re:Cognition Health begins landmark international trial testing finger-prick blood biomarker test for early Alzheimer's diagnosis, potentially replacing invasive methods.
Mabwell's MAIWEIJIAN Denosumab Injection Receives NMPA Acceptance for Expanded Cancer Bone Complications Treatment
China's NMPA accepts Mabwell's supplemental biologics license for MAIWEIJIAN denosumab to prevent bone complications in multiple myeloma and solid tumor patients.
Sedogen Receives U.S. Patent for Diazoxide Treatment of Prader-Willi Syndrome Behavioral Symptoms
Sedogen LLC secures patent 12,589,098 for diazoxide formulations targeting behavioral symptoms in Prader-Willi syndrome, including food-related behaviors.