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Caranx Medical’s TAVIPILOT Soft Receives the US FDA Clearance for Real-Time Guidance of Transcatheter Heart Valve Implantation

Shots:The US FDA has granted clearance to TAVIPILOT Soft for real-time intra-operative guidance of transcatheter heart valve implantationTAVIPILOT Soft, set to launch by the end of 2025, is compatible with all cardiac imaging systems & will support all TAVI heart valves available on the market, thereby, allowing seamless integration in clinical settingsTAVIPILOT…
July 15, 20250Comments

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Ultragenyx Reports the Health Canada’s Approval of Evkeeza (evinacumab) to Treat Children with Homozygous Familial Hypercholesterolemia (HoFH)

Shots:Health Canada has approved label expansion of Evkeeza, as an adjunct to diet & other lipid-lowering therapies, to treat children (≥6mos.) with HoFHApproval was based on model-based analysis that predicted similar or greater LDL-C reductions with Evkeeza (15mg/kg, Q4W) in children (6mos. to 5yrs.) at 24wks. Data from compassionate use in 5 children…
July 15, 20250Comments

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VIEWPOINTS

Retrieving Olfactory Prowess: Rick Geoffrion from Cyrano Therapeutics in Conversation with PharmaShots 

Shots: Recently, Cyrano Therapeutics signed a licensing agreement with Resyca, integrating its novel therapy for post-viral smell loss, CYR-064, with Resyca’s Soft Mist Nasal Spray Technology PharmaShots welcomes Rick Geoffrion, President & CEO of Cyrano Therapeutics, in an illuminating dialogue exchange centered around CYR-064 and its role in treating post-viral hyposmia (smell loss) Rick highlights…
July 14, 20250Comments

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Bayer
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Bayer Reports the US FDA’s Approval of Kerendia (Finerenone) to Treat Heart Failure (HF)

Shots:The US FDA has approved Kerendia/Firialta (10, 20, & 40mg) for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits authorization in China, EU & Japan, with global applications plannedApproval was based on the P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where…
July 14, 20250Comments

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