Regulatory

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.

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.

As trust shifts from a stated value to an operating condition, pharmaceutical leaders face new expectations for how credibility is built, governed and sustained under continuous scrutiny.

Q&A with PwC’s Glenn Hunzinger explores why biopharma M&A investment could approach $300 billion in 2026, how drugmakers are balancing risk amid patent cliffs and policy pressures, and the urgent need to transform healthcare as commercial medical costs climb toward 9%.

FDA has granted accelerated approval to Zenbexus plus daratumumab and Hyaluronidase-fihj and dexamethasone for multiple myeloma after at least one prior line of therapy.

Why pricing pressure, policy volatility and supply-chain risk are pushing drugmakers toward greater cost and portfolio discipline, without losing sight of investment in innovation.

Krieger Scientific’s founder and CEO discusses how various factors, such as siloed systems and misuse of AI, may be responsible for the increase of warning letters from FDA.

President Trump signs an executive order shrinking the recommended childhood vaccine schedule from 18 diseases to 11, and calls for the MMR shot to be split into three separate injections.

Krieger Scientific's Joseph Morwald on why unverified AI-generated documentation in pharma is a complex issue with potentially significant consequences.