NEWS

The US FDA Grants 510(k) Clearance to Medivis’ Spine Navigation Platform

Shots: The US FDA has granted 510(k) clearance to Spine Navigation platform; commercially launched in the US, making it available nationwide to hospitals & ambulatory surgical centers Spine Navigation integrates AI-driven surgical intelligence, real-time insights, & advanced imaging with lightweight AR hardware allowing surgeons ergonomic freedom using hand tracking & voice control in neuro &…

April 3, 2025

SineuGene Therapeutics Reports the US FDA’s IND Clearance of SNUG01 for Amyotrophic Lateral Sclerosis

Shots: The US FDA has granted IND clearance to SNUG01 for ALS SNUG01 will be evaluated in a P-I/IIa dose-escalation & expansion trial to assess its safety, tolerability, & preliminary efficacy in ALS adults; SineuGene to partner with academics & institutions to lead clinical development of SNUG01 SNUG01, a TRIM72-targeted gene therapy, counteracts ALS through…

April 3, 2025

Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)

Shots: The US FDA has granted accelerated approval to Vanrafia for proteinuria reduction in adults with primary IgAN at risk of rapid disease progression based on the ongoing P-III (ALIGN) trial, with no requirement for REMS program; traditional approval will be supported by eGFR results expected in 2026 Trial assessed atrasentan (0.75mg, PO, QD) +…

April 3, 2025

Sanofi Licenses an Undisclosed Nurix Therapeutics’ Drug Program for Autoimmune Diseases

Shots: Sanofi has licensed an undisclosed Nurix program targeting a previously undruggable transcription factor for autoimmune diseases under their Dec 2019 deal As per the deal, Nurix used its DEL-AI platform to develop E3 ligase-targeting degraders, with Sanofi having rights to license them. Nurix can co-develop & co-promote up to 2 US products, sharing US…

April 3, 2025

Averoa Receives the CHMP’s Positive Opinion for Xoanacyl to Treat Chronic Kidney Disease

Shots: The CHMP has recommended Xoanacyl (ferric citrate complex) for chronic kidney disease, with an EU decision expected by Jun 2025, while the UK's MAA will be filed via MHRA's IRP, with decision anticipated in the coming mos. MAA was filed via centralized European procedure in Mar 2024 & was supported by 3 pivotal trials…

April 2, 2025

The US FDA Grants 510(k) Clearance to Teleflex’s AC3 Range Intra-Aortic Balloon Pump (IABP) for Cardiac Patient Mobility

Shots: The US FDA has granted 510(k) clearance to the AC3 Range IABP, which will enter full market release in the US & begin shipping in Q2’25 AC3 Range allows reliable IABP support during multiple pts transport modes, incl. ambulances & fixed or rotary-wing aircraft AC3 Range integrates the AC3 Optimus IABP’s interface & algorithms…

April 2, 2025

Apellis Pharmaceuticals Reports the US FDA’s sNDA Acceptance & Priority Review of Empaveli for C3 Glomerulopathy and Primary IC-MPGN

Shots: The US FDA has accepted sNDA & granted priority review to Empaveli for C3 glomerulopathy (C3G) & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (PDUFA: Jul 28, 2025) Submission was backed by P-III (VALIANT) trial assessing Empaveli (Q2W) vs PBO in C3G & primary IC-MPGN pts (≥12yrs., n=124) for 26wks. followed by 26wk. open-label…

April 2, 2025

Daiichi Sankyo Reports the First Patient Dosing in P-III (DESTINY-Gastric05) Trial of Enhertu Regimen to Treat G/GEJ Cancer

Shots: Daiichi has reported first pts dosing in its P-III (DESTINY-Gastric05) trial assessing Enhertu regimen in 1L, inoperable, locally advanced or metastatic HER2+ (IHC 3+ or IHC 2+/ISH+) G/GEJ cancer pts, with PD-L1 CPS ≥1 Trial will assess efficacy & safety of Enhertu (5.4mg/kg) + Keytruda + fluoropyrimidine-based CT vs trastuzumab + Keytruda + Pt-based…

April 2, 2025

Johnson & Johnson Reports P-III (MARIPOSA) Trial Data of Rybrevant + Lazcluze for EGFRm NSCLC

Shots: J&J reported P-III (MARIPOSA) trial data assessing Rybrevant + Lazcluze vs osimertinib or Lazcluze alone as a 1L treatment of locally advanced or metastatic NSCLC pts (n=1074) with EGFR ex19del or L858R substitution mutations At 37.8mos. mFU, trial showed superior OS, with mOS not reached vs 36.7mos. for osimertinib-treated pts, plus 56% vs 44%…

April 2, 2025

Axsome Therapeutics Reports Topline Data of P-III (PARADIGM) Trial of Solriamfetol for Major Depressive Disorder (MDD) regardless of Excessive Daytime Sleepiness (EDS)

Shots: Axsome reported topline data of PoC P-III (PARADIGM) trial assessing solriamfetol (300mg) vs PBO in MDD pts with severe EDS (ESS ≥16; n=51) & those without severe EDS (n=295) Trial showed no significant MADRS total score change (1EP) in the overall population. However, EDS pts saw depressive symptom improvements across MADRS total score, MADRS…

April 2, 2025

NEWS

The US FDA Grants 510(k) Clearance to Medivis’ Spine Navigation Platform

SineuGene Therapeutics Reports the US FDA’s IND Clearance of SNUG01 for Amyotrophic Lateral Sclerosis

Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)

Sanofi Licenses an Undisclosed Nurix Therapeutics’ Drug Program for Autoimmune Diseases

Averoa Receives the CHMP’s Positive Opinion for Xoanacyl to Treat Chronic Kidney Disease

The US FDA Grants 510(k) Clearance to Teleflex’s AC3 Range Intra-Aortic Balloon Pump (IABP) for Cardiac Patient Mobility

Apellis Pharmaceuticals Reports the US FDA’s sNDA Acceptance & Priority Review of Empaveli for C3 Glomerulopathy and Primary IC-MPGN

Daiichi Sankyo Reports the First Patient Dosing in P-III (DESTINY-Gastric05) Trial of Enhertu Regimen to Treat G/GEJ Cancer

Johnson & Johnson Reports P-III (MARIPOSA) Trial Data of Rybrevant + Lazcluze for EGFRm NSCLC

Axsome Therapeutics Reports Topline Data of P-III (PARADIGM) Trial of Solriamfetol for Major Depressive Disorder (MDD) regardless of Excessive Daytime Sleepiness (EDS)

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