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The filing follows the completion of a pivotal study targeting abdominal conditions.

FDA approval of Itvisma, the first gene replacement therapy for adolescents, teens, and adults with SMA, is backed by Phase III data showing meaningful gains in motor function and a consistent safety profile across previously untreated and previously treated patients.

In today’s Pharmaceutical Executive Daily, Novo Nordisk faces market pressure after a late-stage trial setback, Moderna takes out a $1.5 billion loan to support its long-term growth plan, and Medicare moves closer to releasing negotiated prices for 15 widely used, high-cost medicines.

Q&A with Krishna Kanumuri, CEO of Sai Life Sciences, on steering a contract development and management organization through growth, scale-up, and the shifting global supply chain in pharma.

Novartis is planing layoffs in Switzerland, along with plans to invest $80 million to enhance RNA treatment production and create new jobs by 2028.

As the federal government prepares to release newly negotiated Medicare drug prices, weight-loss blockbusters Ozempic and Wegovy remain in the spotlight, while CMS advances a model to cut Medicaid spending and broaden access to affordable treatments.

New technologies are helping the industry move toward more predictive and humane approaches.

In the second part of our conversation, Andel co-founder Jay Bregman how new GLP-1 options hitting the market will amplify existing coverage problems for the near future.

In today’s Pharmaceutical Executive Daily, learn how Tesaro is suing AnaptysBio over alleged contract breaches, Flagship Pioneering and Valo Health announce major new collaborations, and why integrated direct-to-patient drug distribution is becoming a strategic imperative.

Advice for making your story pitch stand out in this treatment space—where clearly conveying the "why it matters" is essential.

Novo Nordisk faces a drop in its stock after its Alzheimer’s trials studying semaglutide fail to show efficacy, raising concerns for future developments.

As affordability, access, and transparency reshape U.S. healthcare, manufacturers are rapidly redefining direct-to-patient drug distribution as a core strategic capability, one that demands fully integrated, data-driven platforms to secure control, competitiveness, and long-term value creation.

In the first part of this video, Dr. Bruce Leuchter, CEO of Neurvati Neuroscience, discusses which areas of neuroscience are exciting investors.

Ryan Conrad, visiting fellow at the Center on Health Policy at the Brookings Institution, continues his conversation about FDA’s Priority Review Voucher Program, and explains what the industry can learn from the announced participants.

In today’s Pharmaceutical Executive Daily, learn how Abbott is acquiring Exact Sciences in a major diagnostics deal, Novartis is building a new manufacturing hub in North Carolina, and the FDA is rolling out a wide batch of drug approvals.

Tesaro and AnaptysBio engage in legal battles over alleged breaches of their 2014 partnership agreement regarding Jemperli.

Pharmaceutical collaborations expand as Flagship Pioneering expands its partnership with GSK, signing agreements with ProFound Therapeutics and Quotient Therapeutics, while Valo Health teams up with Merck KGaA to tackle disease challenges.

Jay Bregman, co-founder of Andel, the cost and operational complexity of covering GLP-1 medications.

In today’s Pharmaceutical Executive Daily, learn how Moderna is expanding its manufacturing footprint in Massachusetts, GSK is advancing new research collaborations under the LTZ Fleming Initiative, and the FDA commissioner highlights how early and late movers can benefit from the National Priority Voucher program.

The FDA approves multiple new drugs, enhancing treatment options for cancer and other conditions.

As part of its multi-billion-dollar investment, the company will be creating a unified, end-to-end manufacturing campus spanning biologics, gene therapy, solid dosage, and packaging operations.

Abbott's acquisition of Exact Sciences enhances cancer diagnostics and expands access to innovative screening and treatment solutions for patients worldwide.

In the first part of our conversation with Ryan Conrad, visiting fellow at the Center on Health Policy at the Brookings Institution, he provides a broad overview of the possible positive and negative impacts of FDA’s Priority Review Voucher Program.

In today’s Pharmaceutical Executive Daily, learn how Novo Nordisk is launching an introductory offer for Wegovy and Ozempic, AbbVie and Genmab gain FDA approval for Epkinly in follicular lymphoma, and Johnson & Johnson announces a $3 billion definitive agreement to acquire Halda Therapeutics.

GSK's collaborations leverage cutting-edge technology and scientific expertise to advance and accelerate research.

Moderna invests $140 million in its Norwood facility, creating hundreds of bio jobs while also enhancing manufacturing presence in the U.S.

The first wave of Commissioner’s National Priority Vouchers signals a fundamental shift in FDA competitiveness, rewarding companies that pair breakthrough science with affordability commitments, onshore manufacturing readiness, and the operational muscle to execute ultra-accelerated reviews.

A US-China Economic and Security Review Commission report highlights China’s tightening grip on APIs, biomanufacturing, and R&D services, raising alarms about supply chain vulnerabilities, data transparency gaps, and the urgent need for US policy action.