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Rocket Pharmaceuticals Receives the US FDA’s RMAT Designation of RP-A601 to Treat PKP2-Arrhythmogenic Cardiomyopathy

Shots: The US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A601 for the treatment of PKP2-arrhythmogenic cardiomyopathy Designation was supported by ongoing P-I trial, where all 3 adults treated with a single dose of RP-A601 (8x10¹³ GC/kg) showed enhanced PKP2 protein expression, incl. 110% & 398% increase in 2 pts with low…

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The US FDA Grants Priority Review to Johnson & Johnson’s TAR-200 for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Shots: The US FDA has granted priority review to NDA of TAR-200 for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS &/or papillary tumors NDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in pts ineligible or opting out of radical cystectomy that showed an 82.4% CR rate & 52.9% remained cancer-free for at…

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The US FDA Approves GSK’s Shingrix Prefilled Syringe Presentation to Protect Individuals Against Shingles

Shots: The US FDA has approved prefilled syringe formulation of Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles (herpes zoster) Approval was supported by data demonstrating its technical comparability to the existing format, which incl. 2 separate vials, a lyophilised antigen & a liquid adjuvant, combined by healthcare professionals before use Additionally, Shingrix prefilled…

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RIVANNA Receives the US FDA 510(k) Clearance for Accuro3S System and SpineNav-AI Image Processing Software

Shots: Accuro 3S ultrasound system & SpineNav-AI received FDA clearance to provide anatomical guidance during needle or catheter placement; further regulatory filings for advanced features are planned, alongside ongoing clinical collaborations, limited release, & upcoming full market launch Accuro 3S is a portable system featuring SpineNav-AI & a Dual-Array convex probe with 2 aligned transducer…

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