Patient Access

FDA expands Dupixent approval to children aged 2–11 with chronic spontaneous urticaria, marking the first biologic option for this population and extending its reach across type 2 inflammatory diseases.

FDA has approved Merck’s Idvynso, introducing a differentiated, two-drug, non-INSTI, tenofovir-free HIV regimen that maintains viral suppression while offering a potentially more tolerable, simplified option for long-term patient management.

Amazon has launched a new GLP-1 weight management program through its One Medical network, integrating obesity treatment into primary care while expanding access to both telehealth services and a range of branded medications.

Enabling highly individualized treatment approaches that align with each patient’s unique physiology, goals, and tolerability, compounding can have a significant impact.

Supply chain chokepoints are converging to expose deep structural vulnerabilities in the U.S. drug supply, with new data showing that even medicines not currently in shortage may be one disruption away from crisis.

Samsung Bioepis’ SVP and head of US commercial discusses the pricing, regulatory, and broader issues impacting the biosimilars market.

Model N’s Michael Grosberg breaks down the accelerated complexity, policy disruption, and data gaps testing manufacturer market access and revenue management strategies.

Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, discusses how the Tecvayli and Darzalex Faspro combination delivers deep, durable responses, along with its rapid FDA review.

Eli Lilly releases new safety data after FDA requested additional data to conduct extensive post-approval safety studies for Foundayo, including long-term monitoring of cardiovascular, liver, and thyroid cancer risks.

A more dynamic, data-driven approach is redefining what “good” looks like in copay support.

FDA has fully approved Travere’s Filspari for focal segmental glomerulosclerosis, making it the first approved therapy for the rare kidney disease and expanding its role beyond IgA nephropathy.

A federal court’s decision to temporarily allow continued mail distribution of mifepristone underscores the ongoing legal and regulatory uncertainty surrounding abortion access.

Novo Nordisk’s U.S. launch of a higher-dose Wegovy formulation highlights Novo's effort to extend efficacy, capture broader patient demand, and reinforce its dominance in the rapidly expanding obesity market.

The importance of aligning cost control with clinical appropriateness and continuity of care.

FDA has approved Foundayo, Eli Lilly's once-daily oral GLP-1 receptor agonist, as the first small molecule pill of its kind for obesity.

Novo Nordisk launched a multi-month Wegovy subscription program offering fixed monthly pricing through telehealth providers, aiming to improve affordability and long-term adherence among self-pay patients.

A nationally representative survey of more than 20,000 U.S. adults found that 33% made at least one daily spending trade-off to pay for healthcare in the past year

Arexvy is now approved for adults aged 18 to 49 with underlying conditions that elevate their risk of severe RSV disease.

Testing reveals that compounded tirzepatide products mixed with vitamin B12 contain a chemical impurity of unknown toxicity.

Eli Lilly launches Employer Connect, a new platform linking employers with benefit administrators and a pharmacy network to expand affordable access to its obesity medication Zepbound for U.S. workers.

Britain’s MHRA intensifies enforcement against illegal weight-loss drugs, seizing nearly 2,000 doses and equipment amid rising global demand for obesity treatments.

David Graziano, head of retail network at GoodRx, says the FDA’s crackdown on non-approved or “copycat” GLP-1 drugs could shift demand toward FDA-approved therapies while increasing the importance of affordable access through retail pharmacies.

The new once-monthly dosing schedule for Rybrevant Faspro in combination with Lazcluze offers a more convenient option and also maintains efficacy and safety comparable to the prior bi-weekly regimen.

Hims & Hers moved to remove access to its compounded semaglutide offering following mounting regulatory scrutiny and legal pressure from Novo Nordisk.

Veradermics’ above-range IPO highlights renewed investor selectivity in biotech, favoring late-stage companies with clear clinical milestones and exposure to large, consumer-driven markets.