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- 2. PAPZIMEOS May 11, 2026PAPZIMEOS was granted full approval by the US Food and Drug Administration (FDA) in August 2025, becoming the first and only approved therapy for the treatment of adults with RRP. PAPZIMEOS approval was supported by results from the pivotal Phase 1/2 study, which successfully met its primary safety and pre-specified primary eZicacy endpoints. Click here […]
- 3. Zanidatamab-hrii May 11, 2026Zanidatamab-hrii received Food and Drug Administration (FDA) approval for the treatment of adults with previously treated, unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive (immunohistochemistry [IHC] 3+) biliary tract cancer (BTC), as detected by an FDA-approved test, on November 20, 2024. This indication is approved under accelerated approval based on overall response rate […]
- 0. Dyne Therapeutics May 11, 2026Dyne Therapeutics shared positive topline results from its Phase 1/2 trial of the investigational drug, zeleciment rostudirsen (also known as DYNE-251), in individuals with Duchenne muscular dystrophy amenable to exon 51 skipping. The study met its primary endpoint, demonstrating a statistically significant increase in dystrophin from baseline at 6 months. Furthermore, the treatment maintained a […]
- 1. Boston Scientific received U.S. Food and Drug Administration (FDA) 510(k) clearance May 11, 2026Boston Scientific received U.S. Food and Drug Administration (FDA) 510(k) clearance for the expanded indication of Rezūm™ Water Vapor Therapy, increasing the maximum prostate volume that can be treated with the device from 80 cm3 to 150 cm3 for patients with benign prostatic hyperplasia (BPH). Existing real-world and clinical trial data for Rezūm Therapy demonstrates […]
- 8. LivaNova May 11, 2026LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, has announced that the journal Brain Stimulation has published two pivotal articles chronicling the unipolar cohort data set for the RECOVER clinical study. The researchers evaluated the safety and efficacy of LivaNova's VNS Therapy™ System and its effectiveness on quality of life and daily function in […]
- Value-based pharmacy model helps boost care quality May 11, 2026Ben Shirley, senior director of performance measurement at PQA, explores how community pharmacies can thrive in value-based care by shifting away from fee-for-service reimbursement and focusing on measurable improvements in patient outcomes.
- Can the 988 crisis lifeline keep up with demand amid ongoing staffing shortages? May 11, 2026The U.S. national crisis hotline, 988, was contacted over 18 million times since its launch in July of 2022; however, despite its necessity, many centers are struggling to recruit and retain staff and funding, according to a new study published in "JAMA Network Open."
- 6. NAMCP VBCC May 11, 2026NAMCP understands the changing landscape with regard to the delivery of healthcare moving from the traditional fee for service model to more of a focus on value based care and all of the complexities therein. The mission of the VBCC is to help payers and medical directors in their efforts to more effectively and efficiently […]
- The scale divide: Competing strategies in AI drug discovery May 11, 2026Two approaches to AI in preclinical drug discovery are diverging, from multi-thousand GPU systems to models with only a handful of parameters, with early results raising questions about which will deliver.
- Biotech investors gamble on M&A. Some drugmakers are betting on themselves instead. May 11, 2026Young biotechs usually get acquired instead of maturing into profitable companies. But of late, a growing number are trying — and succeeding.
