Neuspera Medical’s Integrated Sacral Neuromodulation System Secures the US FDA Approval for Urinary Urge Incontinence

Shots: The US FDA has approved integrated sacral neuromodulation (iSNM) system to treat urinary urge incontinence (UUI) iSNM device was evaluated in a P-II trial in 128 pts, which showed 84.2% pts achieved ≥50% reduction in urgent leaks, with 84% & 42% responders experiencing >75% & 100% reduction, respectively in UUI symptoms at 6mos.; 3.5x…

ByRidhi RastogiJune 19, 2025

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AbbVie Reports Topline P-III (TEMPLE) Trial Data on Qulipta (Atogepant) for Migraine Prevention

Shots: The P-III (TEMPLE) trial assessed Qulipta (60mg, QD) vs the highest tolerated dose of topiramate (50, 75 or 100mg; QD) over 24wks. in 545 adults with ≥4 monthly migraine days (MMD) across 73 sites in the EU, Israel & Canada, followed by a 52wk. open-label phase, where all pts received Qulipta Trial met its…

ByRidhi RastogiJune 19, 2025

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Incyte’s Monjuvi Regimen Receives the US FDA Approval for R/R Follicular Lymphoma

Shots: The US FDA has approved Monjuvi (tafasitamab-cxix) + rituximab & lenalidomide for the treatment of adult pts with r/r follicular lymphoma (FL) Approval was based on the P-III (inMIND) trial assessing Monjuvi regimen vs PBO + rituximab & lenalidomide in adults (n=654) with r/r Grade 1 to 3a FL or r/r nodal, splenic or…

ByRidhi RastogiJune 19, 2025

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Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: FDA has approved Yeztugo for PrEP in individuals (≥35kgs) at risk of HIV. MAA & EU-M4all filing are under EMA review, with ongoing reviews in Australia, Brazil, Canada, & South Africa; further filings are planned in Argentina, Mexico, & Peru Approval was based on P-III (PURPOSE 1 & 2) trials assessing Yeztugo (SC; twice…

ByRidhi RastogiJune 19, 2025

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Brain Navi Biotechnology Reports the US FDA’s 510(k) Clearance of NaoTrac for Neurosurgical Procedures

Shots: Brain Navi Biotechnology has received the US FDA’s 510(k) clearance for NaoTrac neurosurgical robot NaoTrac is a stereotaxic guiding surgical device that uses SMART tech for rapid, non-contact, frameless registration by aligning the pts anatomy with preoperative imaging, & a robotic arm to guide instruments while keeping the surgeon in control NaoTrac integrates AI…

ByRidhi RastogiJune 18, 2025

NEWS

Galderma to Present OLYMPIA Extension Study Data on Nemluvio for Prurigo Nodularis at ICD 2025

Shots: The OLYMPIA long-term extension study assessed Nemluvio in 508 pts with prurigo nodularis up to 4yrs., which were enrolled from the P-II or P-III (OLYMPIA 1 & 2) trials Interim analysis at Wk. 100 showed sustained improvement, with over 90% achieving ≥4-point itch reduction & 70% being itch-free or nearly itch-free per Peak-Pruritus Numerical…

ByRidhi RastogiJune 18, 2025

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Processa Pharmaceuticals and Intact Therapeutics Enter Binding Term Sheet for PCS12852 Licensing Deal

Shots: Processa & Intact have entered into a binding term sheet for granting Intact an exclusive option to license PCS12852 for gastroparesis & other GI motility disorders As per the deal, Processa will receive a 3.5% equity in Intact at closing, $2.5M option fee, ~$20M in development & regulatory milestones, ~$432.5M in commercial milestones, &…

ByRidhi RastogiJune 18, 2025

NEWS

Camurus Reports Topline P-IIb (POSITANO) Trial Data on CAM2029 for Symptomatic Polycystic Liver Disease

Shots: Camurus has reported topline P-IIb (POSITANO) trial data assessing 2 dosing regimens of CAM2029 (octreotide SC depot) vs PBO in 71 pts with symptomatic polycystic liver disease (PLD), with pts continuing treatment in a 2.5yr. OLE study Trial met its 1EP with a 4.3% relative reduction in height-adjusted liver volume at Wk. 53 for…

ByRidhi RastogiJune 18, 2025

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Avata Biosciences Enters a Co-Development and Licensing Deal with Oceanus Bio for AVAT-021 and AVAT-022 to Treat Epilepsy and Schizophrenia

Shots: Avata has entered into a co-development & licensing deal with Oceanus Bio for exclusive rights to AVAT-021 & AVAT-022 in Japan & Asia, excl. China & India As per the deal, Avata will receive $95M in co-development contributions, regulatory & sales milestones, plus double-digit royalties on sales, while Oceanus will lead regulatory activities &…

ByRidhi RastogiJune 18, 2025

NEWS

Bayer Reports the US FDA’s NDA Submission of Gadoquatrane for Contrast-Enhanced MRI

Shots: The US FDA has received NDA of gadoquatrane (0.04mmol Gd/kg body weight) for contrast-enhanced MRI of the CNS & other body regions (OBR) in adults & pediatric pts incl. term neonates; MAA was submitted to MHLW with further filings planned in coming mos. NDA was supported by the QUANTI clinical program, which incl. 2…

ByRidhi RastogiJune 18, 2025

Ridhi Rastogi

Neuspera Medical’s Integrated Sacral Neuromodulation System Secures the US FDA Approval for Urinary Urge Incontinence

AbbVie Reports Topline P-III (TEMPLE) Trial Data on Qulipta (Atogepant) for Migraine Prevention

Incyte’s Monjuvi Regimen Receives the US FDA Approval for R/R Follicular Lymphoma

Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Brain Navi Biotechnology Reports the US FDA’s 510(k) Clearance of NaoTrac for Neurosurgical Procedures

Galderma to Present OLYMPIA Extension Study Data on Nemluvio for Prurigo Nodularis at ICD 2025

Processa Pharmaceuticals and Intact Therapeutics Enter Binding Term Sheet for PCS12852 Licensing Deal

Camurus Reports Topline P-IIb (POSITANO) Trial Data on CAM2029 for Symptomatic Polycystic Liver Disease

Avata Biosciences Enters a Co-Development and Licensing Deal with Oceanus Bio for AVAT-021 and AVAT-022 to Treat Epilepsy and Schizophrenia

Bayer Reports the US FDA’s NDA Submission of Gadoquatrane for Contrast-Enhanced MRI

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