Regulatory

FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health.

FDA approval of Vanda’s Nereus marks a rare and meaningful regulatory milestone, introducing the first new pharmacologic option for motion sickness in decades and underscoring renewed innovation in a long-neglected but widely impactful condition.

The approval marks the first agency-cleared oral formulation of a GLP-1 drug for obesity.

Roche’s FDA approval of Lunsumio VELO as a one-minute subcutaneous bispecific therapy for relapsed or refractory follicular lymphoma marks a meaningful advance in reducing treatment burden while preserving strong response rates in later-line disease.

Nine more companies have joined the DTC government-run website, which is set to launch sometime next year.

The bill was part of the larger Defense Bill and will impact funding available to certain foreign companies.

Novo Nordisk’s NDA filing for CagriSema positions the first fixed-dose amylin–GLP-1 combination as a potential next-generation obesity therapy, backed by Phase III data showing more than 20% weight loss and signaling the company’s intent to extend its leadership beyond single-mechanism incretins.

The representatives from Pennsylvania and New York, joined with Democrats to force a vote on legislation against Speaker Johnson’s wishes.

The approval is supported by Phase III SWIFT-1 and SWIFT-2 trial data showing that twice-yearly dosing of Exdensur significantly reduced annualized asthma exacerbation rates compared with placebo when added to standard of care.

The approval is based on Phase III DESTINY-Breast09 data showing the Enhertu–Perjeta combination significantly improved progression-free survival compared with the current taxane-based standard of care in previously untreated metastatic disease.

The FDA’s approval of Lerochol introduces a once-monthly, subcutaneous PCSK9 inhibitor for lowering LDL cholesterol in adults with hypercholesterolemia.

The 16th addition to the FDA Commissioner’s National Priority Voucher pilot program follows Phase III MajesTEC-3 trial data showing significant survival benefits for the Tecvayli-based regimen compared with standard of care in treating relapsed or refractory multiple myeloma.

The FDA’s approval of Uplizna for antibody-positive generalized myasthenia gravis introduces a twice-yearly CD19-targeted therapy option for the rare autoimmune condition.

TrumpRx’s promised drug-price cuts expose a deeper systemic flaw, positioning direct-to-patient clinical pathways as the infrastructure pharma must build to turn political headlines into real access and outcomes.

In the third and final part of her conversation with Pharmaceutical Executive, discusses the ways that regulatory agencies in major global markets are acting in similar ways to have a positive impact on the biosimilars market.

Experts weigh in on FDA’s new accelerated review program, revealing what companies stand to benefit the most from the initiative.

Amid the US reshoring push, drugmakers navigate geopolitical and supply chain risks.

In the second part of her conversation with Pharmaceutical Executive, Gillian Woollett, VP and head of regulatory strategy at Samsung Bioepis, explains the direct impact changes at FDA have on the biosimilar space.

FDA’s approval of Augmentin XR as the first therapy cleared under the new National Priority Voucher Pilot Program signals a decisive push to strengthen domestic antibiotic manufacturing, accelerate critical drug reviews, and stabilize long-strained U.S. antimicrobial supply chains.

New FDA guidance signals a major shift for CAR-T development, calling for randomized trials with standard-of-care control groups and clear evidence of superiority over existing therapies, while simultaneously easing REMS requirements to reduce logistical burdens for treatment centers and patients.

Welcome to Pharm Exec's new guest column on navigating the geopolitical risks challenging core company strategies in today's shifting global landscape for healthcare.

Gillian Woollett, VP and head of regulatory strategy at Samsung Bioepis, discusses how the current regulatory climate is the result of years of work.

FDA’s approval of Bristol Myers Squibb’s Breyanzi as the first CAR T therapy for relapsed or refractory marginal zone lymphoma underscores the therapy’s expanding leadership in B-cell malignancies, backed by compelling Phase II data

Twelve former FDA leaders have publicly challenged the agency’s proposed overhaul of vaccine approvals, sparked by an internal memo linking child deaths to COVID-19 vaccination, arguing the changes threaten evidence-based standards, weaken immunobridging practices, and risk eroding public trust.

The agency based its approval off results collected from the Bruin CLL-321 trial.