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🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
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FDA Approves Skin-Renew: New Indication for Severe Eczema
The FDA has granted approval for Skin-Renew, a groundbreaking treatment for severe eczema, providing patients with a new option for managing their condition.
FDA Updates Diabetes Therapy Label: Key Safety Warning Changes
The FDA has issued important updates to the Metformin diabetes therapy label, introducing key safety warnings to improve patient safety and treatment outcomes.
FDA Approves GenoPharm's Geno-Cure for Targeted Cancer Treatment
GenoPharm's Geno-Cure has received FDA approval, marking a significant advancement in targeted cancer treatment and personalized medicine.
FDA Approves AllerClear OTC: What You Need to Know
AllerClear OTC has been approved by the FDA for effective allergy relief, providing a new option for those seeking over-the-counter solutions.
FDA Approves Bact-Away: Novel Antibiotic Against Resistant Infections
The FDA has approved Bact-Away, a groundbreaking antibiotic designed to combat resistant infections, marking a significant advancement in antibiotic therapy.
FDA Approves AI-Driven Drug ALGO-1 for Treatment-Resistant Depression
The FDA has approved ALGO-1, an innovative AI-driven drug designed to treat treatment-resistant depression, marking a significant advancement in mental health care.
FDA Approves Semaglutide Trial Update for Obesity Treatment
The FDA has approved an update to the Semaglutide trial, enhancing its potential as a groundbreaking treatment for obesity.
Revolution Medicines Presents Updated Zoldonrasib Phase 1 Data for KRAS G12D Lung Cancer at AACR 2026
Revolution Medicines shares updated Phase 1 clinical trial results for zoldonrasib, targeting KRAS G12D non-small cell lung cancer patients at AACR 2026.
EpiBiologics Begins Phase 1 Trial of EPI-326 Bispecific Antibody for EGFR-Driven Cancers
EpiBiologics doses first patient with EPI-326, a tissue-selective bispecific antibody targeting EGFR-driven solid tumors in global Phase 1 study.
SBC Medical Group Holdings Prices 3.1 Million Share Secondary Offering at Market Rate
SBC Medical Group Holdings announces pricing of 3.1 million share secondary offering by major stockholder Dr. Yoshiyuki Aikawa in latest corporate move.
FDA Terminates Recall of Gas Delivery Engine Ventilator Model 16650A After Safety Review
FDA has terminated the recall of Gas Delivery Engine ventilator model 16650A, originally initiated in May 2016 for patient safety concerns.
Philip Morris International Receives FDA Reauthorization for IQOS Modified Risk Tobacco Product
FDA renews Philip Morris International's modified risk tobacco product authorization for IQOS devices and HEETS consumables, allowing continued reduced-exposure claims.
Ascentage Pharma Presents Four Preclinical Cancer Studies at AACR 2026 Annual Meeting
Ascentage Pharma showcases four promising preclinical studies on combination cancer therapies at AACR 2026, demonstrating potential for novel treatments.
Whitehawk Therapeutics HWK-007 Shows Promise in AACR 2026 ADC Data Presentation
Whitehawk Therapeutics presents preclinical data for HWK-007, HWK-016, and HWK-206 ADCs at AACR 2026, with Phase 1 trials ongoing for lead candidates.
Pulnovo Medical Secures $100 Million Investment from Medtronic for Pulmonary Hypertension Therapies
Pulnovo Medical raises $100M in oversubscribed funding led by Medtronic to advance breakthrough pulmonary hypertension and heart failure treatments.
Nuance Pharma's Ohtuvayre Shows Improved Lung Function in Chinese COPD Patients - ENHANCE-CHINA Phase 3 Results Published
Nuance Pharma announces CHEST journal publication of Phase 3 ENHANCE-CHINA trial showing Ohtuvayre (ensifentrine) improved lung function in Chinese COPD patients.
Lundbeck's VYEPTI Shows Improvement in Migraine-Related Cognitive Symptoms in Real-World INFUSE Study
Lundbeck presents 6-month INFUSE study data showing VYEPTI (eptinezumab) improves migraine-related cognitive symptoms in patients with prior anti-CGRP failures.
FDA Approves BioClone's Clone-Remicade: Cheaper Alternative to Remicade
BioClone's Clone-Remicade has received FDA approval, offering a more affordable option for patients requiring treatment for autoimmune diseases, similar to Remicade.
FDA Priority Review ArterioFlow: Accelerating PAD Treatment
The FDA's Priority Review designation for ArterioFlow promises to expedite treatment options for patients suffering from Peripheral Artery Disease (PAD).
FDA Approves V-Protect Vaccine: Key Details on ViroDefense’s New Tool
ViroDefense's newly approved V-Protect vaccine promises to bolster immunity against viral infections, marking a significant advancement in public health.