Report Store Get Proposal

Home Blog Notizia

Notizia - Recent Pharma, Healthcare and Biotech Happenings

pharma-news-for-beam-astrazeneca-sanofi

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Sanofi’s Qfitlia Becomes First FDA-Approved Therapy for Hemophilia A or B; FDA Approves AstraZeneca’s IMFINZI as First Perioperative Immunotherapy for Bladder Cancer; Beam Therapeutics’ BEAM-302 for AATD Receives FDA Clearance; AstraZeneca’s CALQUENCE Combo Greenlit in EU for Mantle Cell Lymphoma; Ionis’ WAINZUA Wins EU Approval for Hereditary Transthyretin Amyloidosis

Sanofi’s Qfitlia Becomes First US-Approved Therapy for Hemophilia A or B The FDA has approved Qfitlia (fitusiran), the first antithrombin-lowering therapy for routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A or hemophilia B patients (ages 12+) with or without inhibitors. Approval is based on ATLAS Phase III trials, which showed a 71% reduction in annualized bleeding rates (ABR) for patients without inhibitors and a 73% reduction for those with inhibitors. Qfitlia uses small-interfering RNA technology, allowing low-frequency, subcutaneous dosing. “Current treatment options force trade-offs between bleed control and convenience,” said Ph...

Explore More...

medtech-news-of-alcon-abbott-okami

Alcon Gains CE Mark for Clareon Vivity IOL in Europe; MicroPort MedBot’s Toumai SP Robot Wins NMPA Approval; Abbott Launches Intravascular Lithotripsy Trial; BD Advances GalaFLEX LITE™ Clinical Trial; GE HealthCare Unveils AI-Powered Invenia ABUS Premium; Okami Medical Introduces SENDERO® MAX Catheter

pharma-news-for-telix-merck-alnylam

Clover’s SCB-1019 RSV Revaccination Study Clears U.S. IND; FDA Approves AMVUTTRA for ATTR-CM CV Risk Reduction; Pembrolizumab Combo Greenlit for HER2+ Gastric/GEJ Cancer; TREMFYA Becomes First IL-23 Inhibitor Approved for Crohn’s; FDA OKs GOZELLIX for Prostate Cancer Imaging

medtech-news-for-telix-revbio-insulet

Illuccix Receives Dutch Approval for PSMA-PET Imaging in Prostate Cancer; FDA Approves Valcare Medical’s Early Feasibility Study for Novel Amend™ Trans-Septal System; RevBio Launches Pivotal Clinical Trial in Europe for Dental Implant Stabilization; Insulet’s RADIANT Trial Highlights Improved Glycemic Outcomes with Omnipod® 5 Following Direct Transition; Envoy Medical Raises $10 Million to Drive Clinical Progress on Next-Gen Hearing Device; Vave Health Unveils World’s First Wireless Whole-Body Ultrasound with Single PZT Transducer

pharma-news-for-alexion-encell-sydnexis

FDA Expands SOLIRIS for Pediatric Myasthenia Gravis; vTv’s Cadisegliatin Program Resumes as FDA Lifts Hold; ENCell’s EN001 Wins Orphan Drug Designation for Charcot-Marie-Tooth; FDA Accepts Sydnexis’ NDA for SYD-101 in Pediatric Myopia; Cambium Bio’s Potency Assay Strategy Cleared for Elate Ocular Phase III Trials

medtech-news-for-caristo-lindus-health-gt-metabolic

Caristo Wins FDA Clearance for AI Solution to Prevent Heart Attacks; Lindus Health and Sooma Medical Announce Key Clinical Trial for MDD Device; GT Metabolic Secures FDA Clearance for Expanded 50mm MagDI System; Beckman Coulter’s DxC 500i Integrated Analyzer Earns FDA Clearance for Enhanced Diagnostics

pharma-news-for-neurotech-capricor-celltrion

Neurotech’s ENCELTO Becomes First FDA-Approved Treatment for MacTel Type 2; Plus Therapeutics’ Rhenium Obisbemeda Gets FDA Orphan Status; Novo Nordisk Cuts WEGOVY to $499/Month; Capricor’s Deramiocel Wins FDA Priority Review; Celltrion’s OMLYCLO Becomes First Interchangeable XOLAIR Biosimilar

medtech-news-for-abanzza-cerus-inspira

ABANZA Secures FDA 510(k) Clearance for WasherCap™ Mini; Cerus Corporation Secures CE Mark for Next-Gen INTERCEPT Illumination Device; Spinal Stabilization Technologies Enrolls First U.S. Patient in IDE Trial for PerQdisc™; Inspira Technologies Reports Positive Clinical Results for AI-Integrated HYLA Blood Sensor; iCAD and RamSoft Partner to Expand ProFound AI Mammography Solutions in North America; Pulnovo Medical Secures Nearly $100M in Series C Funding

pharma-news-for-precigen-pyxis-defloria

PRGN-2012 Wins Priority Review for Recurrent Respiratory Papillomatosis; PYX-201 Granted Fast Track for R/M HNSCC; AJA001 IND Cleared for Autism Spectrum Disorder; LAE120 IND Approved for Advanced Solid Tumors; Relacorilant NDA Accepted for Hypercortisolism Treatment

medtech-news-for-medtronic-biomerica-alcon

Medtronic Secures FDA Approval for First-Ever Adaptive Deep Brain Stimulation System for Parkinson’s; FDA Grants Breakthrough Device Designation to Averto Medical’s ColoSeal™ System; Biomerica’s inFoods® IBS clinical trial findings were published in Gastroenterology; Lungpacer Medical’s STIMULUS Trial Highlights Improved Hemodynamics With Diaphragm Neurostimulation; Alcon Introduces Voyager DSLT; Stryker Finalizes Acquisition of Inari Medical

pharma-news-for-signet-bavarian-indivior

CTEXLI Approved for Cerebrotendinous Xanthomatosis; SIGX1094 Wins Fast Track for Diffuse Gastric Cancer; Bavarian Nordic’s Chikungunya Vaccine Cleared for Ages 12+; UX111 Gene Therapy Gains Priority Review for Sanfilippo Syndrome; SUBLOCADE Label Update Approved

medtech-news-for-clearpoint-neuro-volta-medical-whiteswell

FDA Grants 510(k) Clearance to Neonav® ECG Tip Location System; ClearPoint Neuro Secures EU MDR Certification for SmartFlow Cannula; Volta Medical’s AI-Driven Ablation Procedure Improves Outcomes in Persistent Atrial Fibrillation Trial; WhiteSwell Presents New Clinical Data on eLym System for Acute Heart Failure Treatment; J&J MedTech Introduces CEREGLIDE™ 92 Catheter System; Thermo Fisher Launches New Spatial Imaging System for Tissue Proteomics

pharma-news-for-galderma-gsk-astellas

EU Approves Galderma’s NEMLUVIO for Atopic Dermatitis and Prurigo Nodularis; GSK’s Penmenvy Wins FDA Nod; Ono Pharmaceuticals’ ROMVIMZA Gets Green Light from FDA for Symptomatic TGCT; Bristol Myers Squibb Updates on RELATIVITY-098 Phase III Trial Findings; FDA Expands Label for Astellas’ IZERVAY in Geographic Atrophy Treatment

medtech-news-for-agiliti-kubtc-neuvotion

Agiliti Launches Essentia; KUBTEC Introduces PICASSO Plus; FDA Clears Neuvotion’s NeuStim™ for Non-Invasive Hand Stimulation in Stroke & SCI Patients; Ibex Medical Analytics Achieves Milestone with FDA 510(k) Clearance; BlueWind Medical Reports Strong Two-Year Outcomes for Revi® System in Peer-Reviewed Study; Reprieve Cardiovascular’s FASTR Pilot Trial Shows Positive Outcomes, FDA Approves IDE for Next Phase

pharma-news-for-biodexa-abbvie-insmed

Immix Bio’s NXC-201 Gets FDA RMAT for AL Amyloidosis; Biodexa’s eRapa Wins Fast Track for Familial Adenomatous Polyposis; AbbVie’s EMBLAVEO Approved for Complicated Intra-Abdominal Infections; Insmed’s Brensocatib Gains Priority Review for Bronchiectasis; Aro Bio’s ABX1100 IND Cleared for Pompe Disease

medtech-news-for-bioretec-honeynaps-aspen

Bioretec Ltd. Gains CE Mark for RemeOs™ Trauma Screw; HoneyNaps’ AI Sleep Diagnostic Software Achieves Recognition as the 73rd and 74th Innovative Medical Devices by South Korea’s MFDS; Movano Health Advances Clinical Trials for Innovative Non-Cuff Blood Pressure Monitor; IRB Approves PathMaker Neurosystems’ MyoRegulator® ALS Study; Aspen Medical Products Closes Deal to Acquire Advanced Orthopaedics; Surmodics Achieves Early Clinical Success with Pounce™ XL Thrombectomy System

pharma-news-for-astrazeneca-vertex-axsome

AstraZeneca Scraps £450M UK Vaccine Factory; FDA Approves First Non-Opioid Pain Reliever JOURNAVX in 20+ Years; Axsome’s SYMBRAVO Wins FDA Nod for Migraine; March Biosciences’ MB-105 Gains FDA Orphan Status for T-Cell Lymphoma; Saol’s SL1009 NDA Accepted for Pyruvate Dehydrogenase Complex Deficiency

Subscribe to our Updates

DelveInsight is dedicated to safeguarding your data. We ensure that your information is handled in compliance with relevant data privacy legislation, our internal guidelines, and our privacy policy.

Receive recent Healthcare updates directly in your inbox.

Daily

Weekly

Monthly