All Blogs
Jul 22, 2025
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 u...
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Jul 21, 2025
Dizal’s ZEGFROVY Approval Heating Up EGFR NSCLC Drug Rivalry with J&J
Eight years after its founding, partly backed by AstraZeneca, Dizal Pharmaceuticals has secured its first FDA approval, receiving accelerated clearance for ZEGFROVY (sunvozertinib)—now the only FDA-approved oral therapy for a rare subset of non-small cell lung cancer (NSCLC). The treatment is indicated for U.S. ...
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Jul 18, 2025
Next-Gen Spinal Cord Injury Therapies: A Look at the Evolving Drug Pipeline
The treatment options for spinal cord injury remain limited, with few approved spinal cord injury therapies available. At present, STEMIRAC is the only approved SCI treatment, and it is offered exclusively in Japan. There is an urgent need for targeted solutions that can enhance patient outcomes and support functio...
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Jul 17, 2025
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™
Medtronic Secured CE Mark for LigaSure™ Technology Integration on Hugo™ Robotic-Assisted Surgery System, Paving the Way for the Future of Surgery On July 15, 2025, Medtronic plc, a global leader in healthcare technology, announced that it received CE Mark approval for its LigaSure™ RAS vessel-sealing techn...
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Jul 16, 2025
Medical Tourism Trends in 2025: What’s New and What’s Next
Medical tourism is rapidly transforming the global healthcare landscape, as more patients cross borders in search of affordable, high-quality treatments and timely care. Driven by the promise of advanced treatments, reduced costs, and shorter wait times, millions seek medical care in countries offering specialized ...
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Jul 15, 2025
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
Nanoscope Therapeutics Begins FDA Rolling Submission for MCO-010 in Retinitis Pigmentosa Nanoscope Therapeutics has initiated a rolling submission of its Biologics License Application (BLA) to the FDA for MCO-010, a first-in-class, gene-agnostic optogenetic therapy targeting severe vision loss due to retinitis p...
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Jul 14, 2025
KalVista’s EKTERLY: First-Ever Oral Hereditary Angioedema Treatment
Following an unexpected regulatory delay last month, KalVista Pharmaceuticals has officially entered the commercial market with the FDA approval of its plasma kallikrein inhibitor, sebetralstat. On July 7, 2025, the FDA cleared sebetralstat, now branded as EKTERLY, as an oral treatment for acute hereditary angioede...
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Jul 11, 2025
Redefining PH-ILD Management: From Prostacyclins to Multi-mechanistic Innovations
Pulmonary hypertension associated with interstitial lung disease (PH-ILD) is a serious, progressive complication characterized by increased Pulmonary Vascular Resistance (PVR) and disrupted gas exchange. This rise in PVR places extra stress on the right side of the heart, eventually leading to right heart dysfuncti...
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Jul 10, 2025
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
Intuitive’s da Vinci 5 Surgical System Received CE Mark On July 02, 2025, Intuitive, widely recognized as a pioneer in robotic-assisted surgery and minimally invasive care, announced that its latest system, the da Vinci 5, had secured CE mark approval for use in both adult and pediatric patients across Eur...
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Jul 09, 2025
The Rise of Menstrual Cups: Revolutionizing Healthcare and Sustainability
Menstrual cups, often referred to as a cup for menstruation, have emerged as a transformative option in feminine hygiene, gaining traction in the menstrual cups market worldwide. But what is a menstruation cup? It’s a reusable, bell-shaped device, typically made from silicone cups for menstruation, crafted from med...
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