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News

Benlysta Autoinjector Approval Transforming Pediatric Lupus Nephritis Management

June 25, 2025 by Shajini

GSK’s Benlysta autoinjector gains FDA nod for pediatric lupus nephritis, enabling at-home treatment.

Categories News Tags At Home Therapy, Benlysta autoinjector, Benlysta autoinjector FDA approval, FDA Approval, GSK, pediatric lupus nephritis treatment

SINTX Enters the $1.3B Foot and Ankle Implants Market with SiNAPTIC Acquisition

December 1, 2025June 25, 2025 by Shajini
Acquisition

SINTX acquires SiNAPTIC assets, targeting the $1.3B foot and ankle fusion implant market.

Categories Dealstreet, News Tags ankle fusion market, foot and ankle fusion market size, foot and ankle implant systems, foot fusion devices, orthopedic medical devices, silicon nitride implants, SINTX acquisition

Digital Pathology Clearance Accelerates U.S. Market Entry

June 25, 2025 by Shajini

PathPresenter wins FDA clearance for digital pathology viewer, advancing primary diagnosis and LIS integration.

Categories Device Approvals, MedTech, News, Regulatory Tags 510(K), Digital Pathology, FDA, FDA cleared digital pathology system

TISSIUM’s De Novo FDA Authorization Signals Industry Shift

December 1, 2025June 25, 2025 by Shajini

FDA De Novo nod for TISSIUM’s COAPTIUM CONNECT: a new era in sutureless nerve repair.

Categories Device Approvals, MedTech, Neurology, News Tags Atraumatic Nerve Repair, DA-approved nerve repair device, De Novo Authorization, FDA, light-activated polymer nerve repair

Revolution Medicines Secures Powerhouse $2B Funding in Groundbreaking Royalty Pharma Deal

June 25, 2025 by Shajini

Revolution inks $2B flexible deal with Royalty Pharma to fund RAS(ON) inhibitors in cancer.

Categories Dealstreet, News Tags Daraxonrasib, Daraxonrasib Phase 3 development, Oncology, RAS-addicted cancers, RAS(ON) inhibitor portfolio funding, Revolution Medicines, Revolution Medicines $2B agreement, Royalty Pharma, Royalty Pharma oncology deal

Arialys Therapeutics Targets First in Class Precision Therapy for Autoimmune Encephalitis

June 23, 2025 by Shajini
a dna strand with bubbles

ART5803 targets NMDA receptor autoantibodies, advancing precision therapy for autoimmune encephalitis.

Categories News, Regulatory Tags anti-NMDAR encephalitis treatment, ART-5803, monoclonal antibody ART5803, NMDA receptor autoantibody blockade, Precision Antibody Therapy, precision therapy for anti-NMDAR

Strategic Industry Context: Alzheimer’s Drug Reimbursement Faces Global Pressure

November 3, 2025June 22, 2025 by Shajini
NICE Backs Age-Based Blood Test to Spot Ovarian Cancer

NICE deems donanemab and lecanemab not cost-effective, blocks NHS coverage for Alzheimer’s drugs.

Categories Market Access, Neurology, News, Pricing and Reimbursement Tags Alzheimer’s Disease, Market Access, NHS Rejection of Donanemab, NICE, Pricing, Reimbursement

ENHERTU Advances First-Line Endometrial Therapy in Phase 3 Trial

June 10, 2025 by Shajini

ENHERTU Phase 3 trial launches for first-line endometrial therapy targeting HER2-expressing tumors.

Categories News, Oncology, Regulatory Tags Phase III

Alexion Strikes Bold AI Partnership for Rare Disease Detection

June 10, 2025 by Shajini
AI - Partnership

AI partnership targets rare bone disease affecting 1 in 6,000 patients.

Categories Dealstreet, News Tags AI/ML, Breakthrough Device, Partnership, Rare disease

ZEISS CLARUS 700 Gains China NMPA Approval for Retinal Imaging

June 10, 2025 by Shajini
Zeiss clarus-700

ZEISS expands retinal diagnostic capabilities in China with CLARUS 700 ultra-widefield imaging system approval.

Categories MedTech, News, Regulatory
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Synopulse Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 24 2025

Synopulse Weekly Pulse – November 24, 2025

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