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Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Sarepta Therapeutics Pauses ELEVIDYS Shipments in U.S. After FDA Intervention Over Patient Deaths; ImCheck’s ICT01 Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia; RedHill Biopharma Gets Positive FDA Feedback on RHB-204 for Crohn’s Disease Approval Pathway; FDA Grants Fast Track Designation to ProMIS Neurosciences’ PMN310 for Alzheimer’s Disease; Oruka Therapeutics Receives IND Clearance for Phase IIa Trial of ORKA-001 in Psoriasis

Sarepta Therapeutics Pauses ELEVIDYS Shipments in U.S. After FDA Intervention Over Patient Deaths Sarepta Therapeutics, Inc. has voluntarily and temporarily paused all shipments of ELEVIDYS (delandistrogene moxeparvovec) in the U.S., effective July 22, 2025, following engagement with the FDA on safety labeling updates. The decision comes amid the ongoing label supplement process and post-marketing safety discussions after adverse events were reported in patients with Duchenne muscular dystrophy (DMD). “As a patient-centric organization, the decision to voluntarily and temporarily pause shipments of ELEVIDYS was a painful one, as individuals with Duchenne are lo...

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medtech-news-for-medtronic-microport-olympus

Medtronic Gains CE Mark for LigaSure™ on Hugo™ Robotic System; J&J Wins FDA Nod for VARIPULSE™ Irrigation Update; DSMB Clears Continuation of Aethlon Medical Clinical Study; MicroPort® CardioFlow Marks First VitaFlow Liberty® Implants in South Korea; Olympus Unveils EU-ME3 Ultrasound Processor in U.S.; QuidelOrtho, BÜHLMANN Launch fCAL® & fPELA® Turbo Assays on VITROS™

pharma-news-for-bayer-klotho-trethera

Nanoscope’s MCO-010 Begins FDA Rolling Submission for Retinitis Pigmentosa; Bayer’s KERENDIA Approved by FDA for Heart Failure With Preserved Ejection Fraction; Klotho Neurosciences’ KLTO-202 Receives FDA Orphan Drug Designation for ALS; Trethera’s TRE-515 Granted FDA Fast Track Designation for Metastatic Prostate Cancer; Adcentrx’s ADRX-0405 Awarded FDA Orphan Drug Designation for Gastric Cancer

medtech-news-for-intuitive-boston-scientific-cerapedics

Intuitive’s da Vinci 5 Gets CE Mark; Boston Scientific’s FARAPULSE™ Secures Expanded FDA Approval; Trividia Health’s TRUE METRIX® Added to Pennsylvania Medicaid List; Cerapedics’ PearlMatrix™ Sees First U.S. Clinical Use Post-FDA Nod; Smith+Nephew Expands Q-FIX◊ with Knotless Option; Cochlear Unveils World’s First Smart Cochlear Implant

pharma-news-for-merck-kalvista-mustang

Merck’s WINREVAIR Granted FDA Priority Review for Pulmonary Arterial Hypertension; KalVista’s EKTERLY Approved by FDA as First Oral On-Demand Therapy for Hereditary Angioedema; Fujifilm’s FF-10832 Receives FDA Orphan Drug Designation for Biliary Tract Cancer; Mustang Bio’s MB-101 Granted FDA Orphan Drug Designation for Glioblastoma and Astrocytomas; Denali’s Tividenofusp Alfa Accepted for FDA Priority Review for Hunter Syndrome

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FDA Clears Stryker’s Incompass Total Ankle System; Glaukos Receives EU MDR Approval for iStent infinite and Key MIGS Devices; STENTiT Announces First Patient Enrollment in Trial of Regenerative Stent for Limb Preservation; Autonomix Medical Treats First Patient in Next Phase (“PoC 2”) of Proof-of-Concept Clinical Trial; Getinge Expands Servo-C Ventilator Capabilities for Neonatal Care; Medtronic Partners With Philips to Advance Patient Monitoring Solutions

pharma-news-for-sobi-gsk-ultragenyx

Sobi’s GAMIFANT Approved by FDA as First Treatment for Macrophage Activation Syndrome in Still’s Disease; GSK Cuts RTS,S Malaria Vaccine Price for Children in Endemic Regions to Under $5; Schrödinger’s SGR-1505 Receives FDA Fast Track Designation for Relapsed/Refractory Waldenström Macroglobulinemia; Ultragenyx’s GTX-102 Granted FDA Breakthrough Therapy Designation for Angelman Syndrome; Eli Lilly’s AMYVID Label Updated by FDA to Support Alzheimer’s Disease Diagnosis

medtech-news-for-ge-healthcare-inspiremd-angiodynamics

GE HealthCare Receives FDA Approval for Expanded Vizamyl PET Imaging Indications in Alzheimer’s Disease Care; FDA Grants Approval to InspireMD’s CGuard® Prime for Carotid Artery Disease; AngioDynamics Launches RECOVER-AV Trial, Marking Milestone in AlphaVac F18⁸⁵ Development for PE Treatment; Tivic Health Concludes Study Optimizing Non-Invasive Vagus Nerve Stimulation Device for Personalized Therapy; Johnson & Johnson Introduces VOLT™ Plating System and ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM in the U.S.

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Incyte’s MONJUVI Combo Approved by FDA for Relapsed/Refractory Follicular Lymphoma; Gilead’s YEZTUGO Becomes First FDA-Approved HIV Prevention with 6-Month Protection; FDA Reviewing Incyte’s OPZELURA for Pediatric Atopic Dermatitis (Ages 2–11); Archeus Technologies Receives FDA Clearance for Prostate Cancer Therapy ART-101; Cycle Pharmaceuticals’ HARLIKU Gets First FDA Approval for Alkaptonuria

medtech-news-for-presidio-medical-creo-medical-penumbra

Presidio Medical™ Gains IDE Nod for ULF™ Study, Names Dimas Jiménez CFO; Creo Medical Gains FDA Nod for SpydrBlade™ Flex, Paving Way for U.S. Launch; Penumbra Completes Patient Enrollment in Pivotal STORM-PE RCT; Adona Medical Completes Enrollment in First-in-Human Trial of Novel Interatrial Shunt for Heart Failure; Johnson & Johnson Launches TECNIS Odyssey Intraocular Lens in Europe, Middle East, and Canada for Enhanced Cataract Care; Philips Sets New Benchmark in POCUS Technology with Flash 5100 Launch

pharma-news-for-celltrion-csl-ocugen

Celltrion Announces FDA Nod for New STEQEYMA Presentation to Broaden Pediatric Use; CSL’s ANDEMBRY Gets FDA Nod as First Factor XIIa Inhibitor for Hereditary Angioedema; Ocugen’s OCU410ST Cleared by FDA to Begin Phase II/III Trial in Stargardt Disease; Milestone Pharmaceuticals Submits FDA Response for CARDAMYST in PSVT; AbbVie’s MAVYRET Approved by FDA as First and Only Therapy for Acute Hepatitis C

medtech-news-for-samsung-masimo-penumbra

Samsung Galaxy Watch Sleep Apnea Feature Cleared for Europe With CE Certification; ZEISS CLARUS 700 Gains NMPA Approval in China; Envoy Medical’s Acclaim® Cochlear Implant Trial Progresses as Planned Following First Month Follow-Up; Masimo SedLine® Shown to Enhance Brain Monitoring Accuracy in Pediatric Anesthesia; Penumbra Launches Ruby® XL System; Johnson & Johnson Introduces the ETHICON™ 4000 Stapler

pharma-news-for-amylyx-cellectar-merck

Amylyx’s AMX0114 Fast Tracked by FDA for ALS; Cellectar’s Iopofosine I 131 Granted FDA Breakthrough in Waldenstrom Macroglobulinemia; YolTech’s YOLT-101 Clears FDA IND for Familial Hypercholesterolemia; Oncovita’s MVdeltaC Gets FDA Orphan Tag for Pleural Mesothelioma; Merck’s ENFLONSIA Approved for RSV Prevention in Infants

medtech-news-for-guardant-health-reflow-medical-bd

Guardant Health’s Shield Test Earns FDA Breakthrough Device Status; Reflow Medical Gains FDA De Novo Clearance for Spur Peripheral Stent System; FastWave Medical Achieves First-in-Human Use of Coronary Laser IVL System; BD Initiates Patient Registry to Assess Rotarex™ System in PAD Treatment; Johnson & Johnson Unveiled the KINCISE™ 2 System for Use in Knee and Hip Revision Surgeries; Cardinal Health Launches Single-Device Solution for Real-Time Tracking of Three Vital Signs

pharma-news-for-beam-incannex-kura

Beam’s BEAM-302 Earns FDA Orphan Drug Tag for AATD; Incannex’s IHL-42X Moves to Phase III After FDA Protocol OK; Kura and Kyowa Kirin’s Ziftomenib Gets FDA Priority Review in NPM1-Mutant AML; GSK’s Linerixibat NDA Accepted by FDA for PBC-Linked Pruritus; Ascendis’ TransCon CNP Granted FDA Priority Review for Achondroplasia

medtech-news-for-olympus-abbott-sensome

Olympus Gains FDA Clearance for EDOF™ Imaging Endoscopes; FDA Approves Abbott’s Tendyne™ Device for Minimally Invasive Mitral Valve Replacement; New Study Validates Exact Sciences’ Oncodetect™ for Enhanced MRD Detection in Stage II-IV Colorectal Cancer; Sensome Completes First-in-Human Trial Enrollment for Lung Cancer Detection System; J&J MedTech Introduces SOUNDSTAR CRYSTAL™ to US Market with Breakthrough 2D Imaging Quality; Terumo Launches ROADSAVER™ Carotid Stent System to Improve Outcomes in Carotid Artery Stenosis

pharma-news-for-gilead -otsuka-liquidia

Gilead’s TRODELVY Shows PFS Benefit in 1L Metastatic TNBC; Otsuka’s Sibeprenlimab Gets FDA Priority Review for IgA Nephropathy; Liquidia Wins FDA Nod for YUTREPIA in PAH and PH-ILD; GSK’s BLENREP Combos Get CHMP Backing in Myeloma; Relief Therapeutics Receives FDA Rare Pediatric Disease Tag for RLF-TD011