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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.

Dave Carey, CEO, Preceptis Medical and Michael Monovoukas, CEO, co-founder, AcuityMD note the importance of shifting ear tube procedures into the office, reducing anesthesia risk, and how AI-driven data and adaptive commercial strategies are becoming critical to scaling new medtech innovations.

DTP programs are redefining the manufacturer’s access operating model.

The guidance provides clarity to drug manufacturers on offering lower drug prices directly to patients, including patients on Medicare and Medicaid.

The FDA's approval is based on results from the Phase III CEPHEUS study, showing deeper and more durable responses compared with standard therapy.

Despite pledges to lower drug costs through Trump-backed pricing deals and direct-to-patient programs, pharmaceutical companies entered 2026 by raising list prices on hundreds of brand-name medicines, underscoring the limited impact of recent policy efforts on the broader U.S. drug pricing landscape.

The president recently announced the healthcare initiative as an effort to bring healthcare price transparency to American patients.















