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🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
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FDA Approves Inno-Med's Inhaler-Tech: Asthma Drug Delivery Innovation
Inno-Med's Inhaler-Tech has received FDA approval, marking a significant advancement in asthma drug delivery technology for improved patient outcomes.
FDA Approves Duo-Boost: New Combo Therapy for Type 2 Diabetes
The FDA has approved Duo-Boost, an innovative combination therapy for Type 2 Diabetes, promising improved blood sugar control and patient outcomes.
FDA Approves RGEN-101: RareGen’s Orphan Drug for Genetic Disorder
The FDA has granted approval for RGEN-101, an innovative orphan drug by RareGen, targeting a rare genetic disorder and promising new treatment options.
FDA Approves Inflammex: Novel Biologic for Ulcerative Colitis
The FDA has granted approval for Inflammex, a groundbreaking biologic designed to treat ulcerative colitis, marking a significant advancement in patient care.
FDA Approves Synapton: Breakthrough for Severe Alzheimer's Treatment
The FDA has approved Synapton, a groundbreaking treatment for severe Alzheimer's, offering new hope for patients and their families.
FDA Approves Generic EpiPen: Key Details on Mylan’s Price Solution
The FDA has approved a generic version of EpiPen, providing a more affordable option for individuals needing emergency treatment for severe allergic reactions.
FDA Approves Prevnar 20 Pediatric Indication Expansion for Pneumococcal Disease
The FDA has expanded the indication for Prevnar 20, allowing its use in pediatric patients to combat pneumococcal disease effectively.
Health Canada Approves Bracco's VUEWAY (Gadopiclenol) for Lower-Dose MRI Contrast Imaging
Health Canada approves Bracco's VUEWAY injection (gadopiclenol) for MRI contrast imaging, enabling lower gadolinium doses while maintaining diagnostic quality.
Salubris Biotherapeutics JK06 Shows Promise in Phase 1/2 Cancer Trial at AACR 2024
Salubris Biotherapeutics presents Phase 1/2 data for JK06, a 5T4-targeted antibody drug conjugate for advanced NSCLC and breast cancer at AACR meeting.
Innate Pharma IPH5201 MATISSE Phase 2 Results Selected for AACR 2026 Clinical Trials Plenary Session
Innate Pharma's IPH5201 anti-CD39 antibody shows encouraging interim results in NSCLC, earning prestigious AACR 2026 plenary session presentation slot.
Accent Therapeutics ATX-295 Shows Promising Anti-Cancer Activity in Preclinical Studies at AACR 2026
Accent Therapeutics presents preclinical data for ATX-295, a novel KIF18A inhibitor showing robust anti-cancer activity in chromosomally unstable tumors.
Zai Lab's ZL-1503 Bispecific Antibody Shows Rapid Itch Relief in Atopic Disease Preclinical Studies
Zai Lab presents promising preclinical data for ZL-1503, an IL-13/IL-31Rα bispecific antibody targeting rapid itch relief and inflammation in atopic diseases.
Zai Lab's ZL-1503 Bispecific Antibody Shows Promise for Rapid Itch Relief in Atopic Dermatitis Preclinical Study
Zai Lab's ZL-1503 IL-13/IL-31Rα bispecific antibody demonstrates rapid itch relief and inflammation reduction in preclinical atopic disease studies.
FDA Reauthorizes Philip Morris IQOS as Modified Risk Tobacco Product for Continued U.S. Marketing
FDA renews Philip Morris International's IQOS modified risk tobacco product authorization, allowing continued reduced-exposure claims for HEETS variants.
Zai Lab's ZL-1503 Bispecific Antibody Shows Rapid Itch Relief in Atopic Disease Preclinical Study
Zai Lab's ZL-1503 IL-13/IL-31Rα bispecific antibody demonstrates sustained suppression of pruritus and inflammation in preclinical atopic disease studies.
Olema Oncology Presents Palazestrant and OP-3136 Preclinical Data at AACR 2026 for Breast Cancer Treatment
Olema Oncology shares new preclinical data for palazestrant SERD therapy and OP-3136 combination at AACR 2026, advancing breast cancer treatment options.
UCB Acquires Neurona Therapeutics for NRTX-1001 Epilepsy Cell Therapy in $XXX Million Deal
UCB announces acquisition of Neurona Therapeutics and lead epilepsy cell therapy NRTX-1001, currently in Phase I/II trials for treatment-resistant epilepsy patients.
Xodus Medical Receives FDA 510(K) Clearance for Hot Pink Pad Surgical Temperature Management System
Xodus Medical launches FDA-cleared Hot Pink Pad for surgical patient temperature management and positioning, improving OR workflows and patient safety.
argenx VYVGART Shows Promise Across Multiple Myasthenia Gravis Subtypes in New AAN 2026 Clinical Data
argenx presents new VYVGART clinical data at AAN 2026, showing efficacy across MG subtypes including ocular MG and potential for earlier CIDP treatment.
Nuvalent's Zidesamtinib Shows Promise in ROS1-Positive Lung Cancer Patients at AACR 2026
Nuvalent presents positive ARROS-1 trial data for zidesamtinib in ROS1-positive NSCLC patients, showing superior brain penetration vs competitors.