
Hannah Clarke
Associate Editor at MJH Life Sciences
Editor, MJH Life Sciences | MPH candidate at Johns Hopkins University | views expressed are my own
Articles
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1 week ago |
urologytimes.com | Hannah Clarke
The FDA has granted a Regenerative Medicine Advanced Therapy (RMAT) Designation to aglatimagene besadenovec (CAN-2409), an investigational off-the-shelf, replication-defective adenovirus for newly diagnosed intermediate- to high-risk localized prostate cancer, Candel Therapeutics announced in a news release.1The therapeutic was previously awarded a Fast Track Designation for the same indication.
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1 week ago |
urologytimes.com | Hannah Clarke
Paclitaxel eluting bioabsorbable implants demonstrated encouraging efficacy and appeared to be safe and feasible in the management of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), according to 6-month data from a phase 1 first-in-human study (NCT06136819).1The bioabsorbable implants are a novel office-based, minimally invasive form of intraprostatic drug elution (IPDE) therapy.
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1 week ago |
urologytimes.com | Hannah Clarke
The European Commission (EC) and Health Canada have approved the subcutaneous (SC) formulation of nivolumab (Opdivo), co-formulated with recombinant human hyaluronidase (rHuPH20; Enhanze), across several previously approved solid tumor indications.1,2,3This includes nivolumab as a monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab (Yervoy) combination therapy, or in combination with chemotherapy or cabozantinib (Cabometyx).
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1 week ago |
urologytimes.com | Hannah Clarke
GSK and Spero Therapeutics announced that the pivotal phase 3 PIVOT-PO trial (NCT06059846) of tebipenem pivoxil hydrobromide (HBr) for complicated urinary tract infection (cUTI) has been stopped early following an interim analysis of the data showing that the trial met its primary end point.1The decision was made based on a recommendation from the Independent Data Monitoring Committee (IDMC), which conducted an analysis of the first 1690 patients in the study.
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1 week ago |
urologytimes.com | Hannah Clarke
Visby Medical has submitted an application to the FDA seeking 510(k) clearance and a clinical laboratory improvement amendments (CLIA) waiver for their point-of-care (POC) Men’s Sexual Health Test, the company shared in a news release.1The single-use, instrument-free test is designed to deliver polymerase chain reaction (PCR) diagnostic results for chlamydia and gonorrhea in approximately 30 minutes using male urine samples. The test can be conducted in men with or without symptoms.
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RT @UrologyTimes: Adam B. Weiner, MD, (@Adam_Weiner535) a urologist at @CS_Urology, discusses prostate cancer screening guidelines in light…

RT @Adam_Weiner535: 🙏 Thank you @UrologyTimes @hannahclarke722 for coverage on the potential cuts to @CDMRP funding "The US leads the worl…

RT @DrPatSoonShiong: A paradigm change in how we approach cancer . Anktiva as a lymphocyte rescue molecule: Unlocking the power of NK cells…