All Blogs
Jul 03, 2025
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
Stryker Received FDA Clearance for Incompass Total Ankle System On June 25, 2025, Stryker, a global leader in medical technologies, announced that the U.S. Food and Drug Administration (FDA) received 510(k) approval for its Incompass™ Total Ankle System. The implant is designed for patients suffering from ...
Read More...
Jul 02, 2025
How the Amniotic Membrane Market is Transforming Regenerative Healthcare Worldwide
The amniotic membrane market is revolutionizing healthcare by harnessing the natural healing power of the amniotic membrane, a thin placental layer renowned for its regenerative properties. This remarkable biomaterial is transforming treatments across specialties, particularly in amniotic membrane eye treatment, wh...
Read More...
Jul 01, 2025
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
FDA Approves Sobi’s GAMIFANT as the First Treatment for Macrophage Activation Syndrome in Still’s Disease In a major advancement for rare inflammatory conditions, the FDA has approved GAMIFANT (emapalumab-lzsg) for the treatment of hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MA...
Read More...
Jun 30, 2025
Gilead YEZTUGO Makes History with First Twice-Yearly HIV Prevention Drug
Gilead Sciences has received a highly anticipated approval from the FDA for its long-acting HIV prevention injection, YEZTUGO (lenacapavir), marking a significant advancement in HIV prevention. On June 18, 2025, the FDA approved YEZTUGO, an injectable HIV-1 capsid inhibitor, for use as pre-exposure prophylaxis (PrE...
Read More...
Jun 27, 2025
The Spinal Cord Injury Treatment Landscape: Limited Progress, Immense Potential
Every year, thousands of lives are changed in an instant by spinal cord injuries—yet most people know surprisingly little about them. Spinal cord injury refers to the abrupt damage to the spinal cord's nerve tissue resulting from trauma, illness, or degenerative conditions. The impact can differ, often leading to u...
Read More...
Jun 26, 2025
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.
GE HealthCare Announced that the FDA Approved Expanded Indications for Vizamyl Pet Imaging Agent for Beta Amyloid Detection, Enabling More Precise Care for Alzheimer’s Patients On June 24, 2025, GE HealthCare announced that the U.S. Food and Drug Administration (FDA) approved an updated label for its PET i...
Read More...
Jun 25, 2025
Myopia Medical Devices That Are Transforming Vision Care
Picture a world where billions struggle to see the stars clearly, where distant landscapes fade into a blur. This is the reality for approximately 2.6 billion people globally living with myopia, a number expected to nearly double to 4.8 billion by 2050, according to the World Health Organization. Myopia, or nearsig...
Read More...
Jun 24, 2025
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
Incyte’s MONJUVI Combo Approved by FDA for Relapsed/Refractory Follicular Lymphoma Incyte has announced that the FDA has approved MONJUVI (tafasitamab-cxix) in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). This makes it the f...
Read More...
Jun 23, 2025
How Could the Approval of JOURNAVX Accelerate the Non-opioids Drug Approval Momentum in Post-Operative Care?
Imagine waking up after successful surgery only to experience moderate-to-severe pain (acute or chronic). For decades, the standard of care (SoC) has been the same for postoperative care: prescribe an opioid. While effective in limiting pain signals, opioids have left behind a baggage of addiction and overdose.&nbs...
Read More...
Jun 20, 2025
Advancements in IgA Nephropathy (IgAN) Treatment: From Standard-of-care (SoC) to Emerging Therapies
IgA Nephropathy (IgAN): Pathogenesis and the Need for Targeted Therapies IgA nephropathy is a complex autoimmune disorder characterized by the accumulation of galactose-deficient IgA1 antibodies in the glomeruli, triggering a cascade of immune responses that ultimately lead to chronic kidney damage. Driven by a ...
Read More...