Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency

Shots: The US FDA has granted 510(k) clearance to Adaptive Nomogram algorithm in the Aurora Xi Plasmapheresis System to improve plasma collection efficiency Clearance was based on a trial of Adaptive Nomogram in Aurora Xi Software Version 2.0 vs the existing Optimized Nomogram involving >52,400 procedures that met its 1EP, depicting increased plasma volume…

BySenior EditorJanuary 29, 2025

NEWS

ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0

Shots: The US FDA has granted 510(k) clearance to ClearPoint Navigation Software 3.0 that will introduce intraoperative CT workflow, expanding its use from MRI. The company is planning to initiate limited market release in Q1’25 & full release in H2’25 Navigation Software 3.0 is compatible with intraoperative CT & Conebeam CT imaging, enabling precision neurosurgery in facilities…

ByRidhi RastogiJanuary 28, 2025

NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies

Shots: The US FDA’s approval of Enhertu for HR+, HER2 low/ultralow MBC, progressed on endocrine therapies, was based on P-III (DESTINY-Breast06) study compared to CT shared at ASCO 2024 & published in The NEJM. AZ will pay $175M for this milestone Study depicted PFS of 36%, mPFS of 13.2 vs 8.1mos., cORR of 62.6%…

BySenior EditorJanuary 28, 2025

NEWS

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Shots: The US FDA has accepted BLA for AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab), with completion of the review process anticipated in Q4’25 Alvotech reported topline results from a confirmatory trial evaluating the efficacy, safety, & immunogenicity of AVT05 vs Simponi in mod. to sev. rheumatoid arthritis patients in Apr…

ByRidhi RastogiJanuary 28, 2025

NEWS

The US FDA Grants Fast Track Designation to Clarity’s Cu-64 SAR-BisPSMA in Biochemical Recurrence of Prostate Cancer

Shots: FDA has granted FTD to Cu-64 SAR-bisPSMA for PET scans of PSMA+ lesions in pts with BCR post-receiving SoC, based on a P-I/II (COBRA) trial assessing it (same & next day) in patients who had an SoC scan at study entry Study showed that it localized disease in ~80% patients & detected double the…

ByRidhi RastogiJanuary 27, 2025

NEWS

Zai Lab’s ZL-1310 Secures the US FDA’s Orphan Drug Designation to Treat Small Cell Lung Cancer (SCLC)

Shots: The US FDA has granted Orphan Drug Designation to Zai Lab’s ZL-1310 for treating small cell lung cancer (SCLC) The designation is based on promising P-Ia/Ib trial data of ZL-1310 as monotherapy and with atezolizumab in treatment-experienced ES-SCLC patients, presented at the ENA Symposium 2024 ZL-1310 is a novel ADC targeting DLL3…

ByRidhi RastogiJanuary 23, 2025

NEWS

Solid Biosciences’ SGT-212 Secures the US FDA’s Fast Track Designation for Treating Friedreich’s Ataxia

Shots: The US FDA has granted FTD to SGT-212 for treating Friedreich’s ataxia (FA) and previously approved its IND on Jan 07, 2025 The P-Ib study will assess safety & tolerability of contemporaneous systemic IV and bilateral IDN administration of SGT-212 in non-ambulatory and ambulatory FA patients for 5yrs., with dosing anticipated during H2’25…

BySenior EditorJanuary 22, 2025

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Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections

Shots: The US FDA has granted 510(k) clearance & CLIA waiver for Cobas liat STI multiplex assay panels (CT/NG & CT/NG/MG), commercially available under the CE mark in upcoming months The CT/NG (chlamydia & gonorrhea) & CT/NG/MG (chlamydia, gonorrhea & Mycoplasma genitalium) assays compliment the existing portfolio of singleplex & multiplex tests of Cobas liat…

ByRidhi RastogiJanuary 22, 2025

NEWS

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

Shots: The US FDA has approved sNDA for Spravato CIII nasal spray to treat MDD patients unresponsive to at least two oral antidepressants, following the FDA Priority Review Approval was based on a multicenter trial that assessed Spravato vs PBO, showing an improved MADRS total score. In a post-hoc analysis, Spravato improved all 10…

ByRidhi RastogiJanuary 22, 2025

NEWS

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the US FDA’s Approval for Mantle Cell Lymphoma (MCL)

Shots: The US FDA has approved Calquence + bendamustine & rituximab for untreated MCL in patients not for autologous HSCT, also transforming its accelerated approval (Oct 2017) to full approval for previously treated MCL. The combination is under review in Australia, Canada, Switzerland, the EU, Japan & other regions Approval was based on P-III…

ByRidhi RastogiJanuary 20, 2025

Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency

ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0

Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

The US FDA Grants Fast Track Designation to Clarity’s Cu-64 SAR-BisPSMA in Biochemical Recurrence of Prostate Cancer

Zai Lab’s ZL-1310 Secures the US FDA’s Orphan Drug Designation to Treat Small Cell Lung Cancer (SCLC)

Solid Biosciences’ SGT-212 Secures the US FDA’s Fast Track Designation for Treating Friedreich’s Ataxia

Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the US FDA’s Approval for Mantle Cell Lymphoma (MCL)

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