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2. PAPZIMEOS April 20, 2026
PAPZIMEOS 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 April 20, 2026
Zanidatamab-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 April 20, 2026
Dyne 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 April 20, 2026
Boston 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 April 20, 2026
LivaNova 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 […]
Clock is ticking: CMS LEAD applications due May 17 for nursing homes, but complexity demands careful review April 20, 2026
The Centers for Medicare and Medicaid Services (CMS) recently opened applications for the Long-Term Enhanced ACO Design model (LEAD) and posted more guidance for prospective participants. The highly anticipated model replaces ACO REACH, which will be discontinued at the end of this year.
43 states have mental health insurance disparities: 4 trends April 20, 2026
The Mental Health Parity Index found 43 states have disparities in access to in-network mental health care and substance use disorder treatment. The tool is an interactive, open-access platform that analyzes payer data to compare access, network participation and reimbursement for mental and physical health services.
6. NAMCP VBCC April 20, 2026
NAMCP 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 […]
'Can it actually deliver?': Why Big Pharma is making the leap to the quantum realm April 20, 2026
Artificial intelligence has long been seen as a way to supercharge drug development. But a whole new frontier of computing is opening up at cutting-edge labs around the globe — and Big Pharmas are getting in on the action.
5 vaccines under development that would change the world as we know it April 20, 2026
The COVID-19 pandemic exposed gaps in pandemic preparedness as the world grappled with a novel pathogen. In an unprecedented effort, vaccines were developed at speed, delivering safe and effective immunizations within 12 months of viral sequencing, a timeline that would have been unthinkable under conventional vaccine development paradigms.

CMS taps 150 digital health companies, providers for ACCESS Model

20 April 2026

The Centers for Medicare and Medicaid Services picked 150 digital health companies and healthcare providers to participate in the launch of its tech-enabled chronic care model.

Clock is ticking: CMS LEAD applications due May 17 for nursing homes, but complexity demands careful review

20 April 2026

The Centers for Medicare and Medicaid Services (CMS) recently opened applications for the Long-Term Enhanced ACO Design model (LEAD) and posted more guidance for prospective participants. The highly anticipated model replaces ACO REACH, which will be discontinued at the end of this year.

Major Medicare, Medicaid reforms could change care for millions

20 April 2026

Federal health officials have proposed sweeping reforms to speed up drug approvals across Medicare, Medicaid and other government-linked health plans.

Getting ahead of the new HIPAA security rule: Practical steps you can take now

20 April 2026

A final rule is expected later this spring, and many of its proposed changes would be time‑consuming and costly for covered entities and business associates to manage. But implementing some of these practices and controls could help.

FDA reminds more than 2,200 sponsors and researchers to disclose trial results

20 April 2026

The U.S. Food and Drug Administration has reminded more than 2,200 medical product companies and researchers of the requirements to submit certain clinical trial results information to ClinicalTrials.gov. Companies and researchers often fail to disclose negative trial results, resulting in significant gaps in the public record and a publication bias that obscures the true landscape of drug development outcomes.