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FDA approves three new therapies spanning autoimmune disease, HIV, and cardiovascular risk, DualityBio and Teva strike major biopharma deals, and Israel Ortiz makes the case for preventive maintenance in manufacturing.

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.

DualityBio has licensed its Dupac next-generation ADC payload platform to Genentech, and Teva has entered a stalking horse bid to acquire BioXcel's Igalmi.

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

ACTO's Parth Khanna on context engineering, role-based design, and why agents should be certified before deployment — just like reps.

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.

Osivax and GC Biopharma agree to co-develop an influenza vaccine combining Osivax's OVX836 with GC Biopharma's GC FLU.

K2 Therapeutics CEO discusses China's biotech rise, the case for global asset acquisition, and what defines a successful biotech.

ACTO CEO Parth Khanna on why sales reps still matter — and how human intelligence plus empathetic agents is the winning formula for field teams.

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.

A new Eli Lilly study links Zepbound to lower healthcare costs in older adults with obesity, Biohaven and Haisco strike major licensing deals with SK Biopharmaceuticals and Sentivera, and Raviv Pryluk makes the case for rethinking clinical trial sample sizing.

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.

A recent study of more than 15,000 adults over 55 with obesity found that sustained Zepbound use was associated with up to 38% lower monthly healthcare costs at 12 months compared with untreated matched controls.

Biohaven grants SK Biopharmaceuticals an exclusive worldwide license to its Kv7 ion channel platform, while Haisco licenses a preclinical type 2 inflammatory disease asset to newly formed Sentivera.

K2 Therapeutics CEO Ying Huang discusses the three priorities that define a successful biotech: unmet need, development cost, and accessible pricing.

ACTO's co-founder on why AI trust equals compliant plus capable — and why role-specific context is what allows agents to achieve both.

Why traditional power calculations leave asset value on the table, and how adaptive frameworks change the math on risk.

FDA approves Imaavy as the first treatment for warm autoimmune hemolytic anemia, McKesson agrees to acquire Precision Medicine Group as Lundbeck partners with Eversana on AI-driven commercialization, and Adam Bartley examines how integrated GMP operating models are reshaping outsourced manufacturing.

Costco’s partnership with SCAN Group suggests that the next competitive advantage in Medicare may come not only from managing insurance risk, but from controlling a trusted consumer healthcare ecosystem.

McKesson has agreed to acquire Precision Medicine Group for $2.25 billion, while Lundbeck has expanded its partnership with Eversana to scale AI-driven workflows.

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.

K2 Therapeutics CEO Ying Huang on the drug development pipeline — and the compounding attrition rates that make FDA approval the exception.

Hanmi Pharm licenses its obesity drug candidate HM17321 to Genentech, James LaValle weighs in after FDA advisors back most nominated peptides for the compounding bulks list, and Ivo Carre examines how tau- and microglia-targeted therapies are reshaping the Alzheimer's pipeline beyond amyloid.

Hanmi Pharm has licensed HM17321 to Genentech for up to $2.3 billion, including a $190 million upfront payment.

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.

K2 Therapeutics CEO Ying Huang on how in-licensing assets with existing human data can cut years and billions from the drug development timeline.

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.