Francis Medical’s Vanquish Water Vapor System Receives the US FDA 510(k) Clearance for Prostate Tissue Ablation

Shots: FDA has granted 510(k) clearance to Vanquish Water Vapor System for prostate tissue ablation in pts with intermediate-risk, localized prostate cancer Clearance was supported by 12mos. follow-up data on 110 pts first enrolled in the ongoing VAPOR 2 trial (n=235) assessing Vanquish System across the US, with longer-term to support PMA submission 6mos. biopsy…

ByRidhi Rastogi4 days ago

NEWS

Cleveland Diagnostics’ IsoPSA Test Receives the US FDA Premarket Authorization for Prostate Cancer Diagnosis

Shots: The US FDA has granted a PMA to the IsoPSA in vitro diagnostic (IVD) kit for the diagnosis of high-grade prostate cancer Approval was based on the clinical evidence from a prospective study of the IsoPSA test conducted at 14 sites across the US, as well as data from supporting analytical validation studies IsoPSA, a…

ByRidhi RastogiDecember 1, 2025

NEWS

J&J Accelerates Cancer Innovation with $3.05B Halda Therapeutics Acquisition

Shots: J&J has entered into a definitive agreement to acquire Halda Therapeutics, strengthening its oncology pipeline As per the deal, J&J will acquire Halda for $3.05B in cash, with the deal treated as a business combination & expected to close in the coming months Acquisition will add Halda’s Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform…

ByRidhi RastogiNovember 18, 2025

NEWS

GSK Secures Exclusive License to Syndivia’s ADC Candidate for Prostate Cancer

Shots: Syndivia has granted GSK exclusive global rights to develop and commercialize a preclinical ADC for the treatment of metastatic castration-resistant prostate cancer (mCRPC) As per the deal, GSK will handle global development, manufacturing, & commercialization of the ADC in exchange for an upfront payment, along with development & commercial milestone payments up to a total of…

ByRidhi RastogiOctober 27, 2025

NEWS

Foresee Pharmaceuticals’ Camcevi ETM Receives the US FDA Approval for Advanced Prostate Cancer

Shots: The US FDA has approved Camcevi ETM (leuprolide mesylate, 21mg, Q3M LAI) for the treatment of advanced prostate cancer; Application is under the EMA’s review Approval was based on P-III trial assessing Camcevi ETM in 144 advanced prostate cancer pts, which showed superior efficacy, with 97.9% pts achieving the 1EP Camcevi (Q6M LAI) is…

ByRidhi RastogiAugust 29, 2025

VIEWPOINTS

Enhancing Diagnostic Capabilities in Prostate Cancer: Raphaël Ortiz from Telix Pharmaceuticals in a Riveting Conversation with PharmaShots

Shots: Telix Pharmaceuticals’ Illuccix is approved in the UK for detecting and localizing prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, using PET imaging. Amidst a shortage of PET imaging agents in the UK and mainland Europe, Telix Pharmaceuticals has secured a significant advantage through an exclusive distribution partnership with Xiel Limited Raphaël…

BySaurabh ChaubeyApril 7, 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

VIEWPOINTS

Astellas at ASCO 2024: Ahsan Arozullah in an Illuminating Dialogue Exchange with PharmaShots

Shots: At ASCO 2024, Astellas Pharma presented 16 abstracts across several types of cancers with unmet medical needs Today at PharmaShots, we have Ahsan Arozullah Sr. VP, Head of Oncology Development, shedding light on the advancement Astellas’ oncology portfolio for urothelial carcinoma, gastric cancer, and prostate cancer Ahsan talks about the presented results from studies…

BySaurabh ChaubeySeptember 16, 2024

CXO TALKS

Spotlight Interview: David Esposito CEO at ONL Therapeutics in a Stimulating Conversation with PharmaShots

“Spotlight-Company of the Month” offers a unique platform for biopharma, life sciences, and healthcare companies, allowing them to connect with their target audiences and like-minded people. This month at PharmaShots’ Spotlight, we had an opportunity to engage in conversation with David Esposito CEO at ONL Therapeutics. David discusses the company's lead candidate ONL1204, which is…

ByHimanshu SehgalFebruary 19, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in August 2023

Shots: The US FDA approved 10 NDAs and 3 BLA in August 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 89 novel products in 2023 In August 2023, the major highlights drugs were Zurzuvae (zuranolone) approval for women with postpartum depression and Veopoz (pozelimab-bbfg) for children…

BySenior EditorSeptember 20, 2023

Francis Medical’s Vanquish Water Vapor System Receives the US FDA 510(k) Clearance for Prostate Tissue Ablation

Cleveland Diagnostics’ IsoPSA Test Receives the US FDA Premarket Authorization for Prostate Cancer Diagnosis

J&J Accelerates Cancer Innovation with $3.05B Halda Therapeutics Acquisition

GSK Secures Exclusive License to Syndivia’s ADC Candidate for Prostate Cancer

Foresee Pharmaceuticals’ Camcevi ETM Receives the US FDA Approval for Advanced Prostate Cancer

Enhancing Diagnostic Capabilities in Prostate Cancer: Raphaël Ortiz from Telix Pharmaceuticals in a Riveting Conversation with PharmaShots

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

Astellas at ASCO 2024: Ahsan Arozullah in an Illuminating Dialogue Exchange with PharmaShots

Spotlight Interview: David Esposito CEO at ONL Therapeutics in a Stimulating Conversation with PharmaShots

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