Regulatory

FDA has approved Ionis Pharmaceuticals' Zanvastro (zilganersen) as the first disease-modifying treatment for Alexander disease.

Nate Hill, co-founder & CEO, Strive Pharmacy, breaks down looming questions around the completed FDA PCAC hearing on peptides.

Carelon Research's Mark Cziraky on why trusted research environments don't change how analysis is done — just how fast and richly it can begin.

Carelon Research's Mark Cziraky on why bringing compute to data — not moving data — reduces risk and accelerates real-world evidence generation.

The Trump administration adds nine drugmakers to its Most Favored Nation pricing program, GSK advances its dual-antigen mRNA flu vaccine into Phase III, and Simcere Zaiming licenses its tri-specific antibody Sim0660 to Roche for up to $1.53 billion.

GSK is advancing its mRNA seasonal influenza vaccine candidate FLUm3HA.b-3NA into a Phase III efficacy trial starting in September.

RBQM implementations fail not because the software is wrong — but because the human environment surrounding it was never engineered.

Nate Hill, co-founder & CEO of Strive Pharmacy, argues that a Category one designation for peptides would give physicians a trusted, regulated channel they currently lack.

Carelon Research's Mark Cziraky on why the industry's need for deeper, linked data is driving a shift toward trusted research environments.

The Trump administration adds nine midsize pharmaceutical companies, including Teva, UCB, Astellas, and BeOne Medicines to its Most-Favored-Nation drug pricing program.

FDA approved Priovant's Lisraya (brepocitinib) as the first targeted therapy for dermatomyositis, Gilead's Bixlenvo as the first once-daily single tablet regimen for virologically suppressed HIV patients, and expanded Mounjaro's label to include cardiovascular risk reduction in high-risk type 2 diabetes patients.

With biopharma batch failures averaging every 40 weeks, predictive maintenance and connected monitoring are becoming critical quality levers.

Osivax and GC Biopharma team up on a next-generation flu vaccine, K2 Therapeutics' Ying Huang talks through why so few drugs make it to market, and the Trump administration opens a new round of Medicaid drug pricing deals.

Beyond tau and TREM2: checkpoint inhibition, inflammasome drugs, brain delivery technologies, and biomarker-led diagnostics reshape Alzheimer's pipeline.

The Trump administration is expected to announce a new round of voluntary MFN drug-pricing agreements with midsize biotech companies as soon as August 31.

The FDA has approved Revolution Medicines' daraxonrasib, the first RAS-directed therapy for previously treated metastatic pancreatic adenocarcinoma, based on a phase 3 trial showing a survival benefit over chemotherapy.

FDA approved Imaavy (nipocalimab-aahu) as the first-ever treatment specifically indicated for warm autoimmune hemolytic anemia in patients ages 12 and up.

Cleanroom hosting with integrated GMP operating models is giving emerging biopharma companies a new middle path between building and full outsourcing.

In the first part of a two-part series, Carre reviews of the tau and TREM2 approaches reshaping Alzheimer's drug development, with key findings from AAIC 2026 in London.

James LaValle, chair of the International Peptide Society, notes how the advisory committee's favorable vote on peptides for the 503A Bulks List was a meaningful step without constituting approval.

From an approval for a disease affecting 900 people worldwide to a new drug class in multiple myeloma and a $322 million biosimilar collaboration — this week's deals and approvals reveal a lot about how pharmaceutical strategy is evolving.

FDA has approved Regeneron's Pasatru ,the first treatment for fibrodysplasia ossificans progressiva in adults.

Rohit Tripathi, VP of Industry Strategy at RELEX, talks with Pharmaceutical Executive about the impact new phased tariffs will have on reshoring pharma manufacturing.

Spherix's VP of market access discusses how the IRA's maximum fair price is reshaping payer strategy, formulary design, and patient out-of-pocket costs far beyond negotiated drugs.

ADVI’s associate director of market access policy strategy discusses how 340B grew to $100 billion, lost its safety-net purpose, and became a compliance nightmare when the IRA arrived.