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FDA Clears Consano’s IND for C-1101Latest Content

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Developing Better Drugs, Not Just More Drugs: Q&A with David Hung

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Gerren McHam, vice president of Government and External Affairs, API Innovation Center, outlines why reshoring API manufacturing requires more than investment incentives.

In today's Pharmaceutical Executive Daily, Invivyd's chief scientific officer discusses a platform designed to predict future viral variants ahead of time, Bristol Myers Squibb expands its AI compute infrastructure with Nvidia to build what it calls the most powerful AI factory in life sciences, and FDA clears Consano Bio's IND for a non-opioid biologic targeting chronic sciatica.

FDA has cleared Consano Bio's IND for C-1101, a platelet-derived biologic delivered via single epidural injection, enabling U.S. expansion of a Phase I trial targeting chronic sciatica.

Bristol Myers Squibb is deploying Nvidia's DGX SuperPOD with Vera Rubin NVL72 systems to build what it claims is the most powerful AI computing infrastructure in life sciences.

Robert Allen, Ph.D., Chief Scientific Officer, outlines how the company's Invymab platform uses viral surveillance and predictive modeling to design monoclonal antibodies against likely future variants rather than current strains.

Gerren McHam, vice president of Government and External Affairs, API Innovation Center, breaks down how China's new export control regulations expose drugmakers to operational risks that have yet to draw significant industry attention.

Nuvation CEO David Hung discusses his leadership style, success stories for building camaraderie, and his inspiration for joining the pharma and biotech industry.

In today's Pharmaceutical Executive Daily, FDA converts Fabhalta's accelerated approval to full approval for IgA nephropathy, a Pharmaceutical Executive commentary argues AI-driven patient support still can't replace human connection, and Jasper Therapeutics closes its acquisition of Kira Pharmaceuticals in a deal combining a three-asset immunology pipeline.

FDA has converted Fabhalta's accelerated approval to a traditional approval for IgA nephropathy after confirmatory Phase III data showed the oral complement inhibitor slowed annual kidney function decline.

Jasper Therapeutics has closed its all-stock acquisition of Kira Pharmaceuticals and raised $132 million in concurrent financing, combining a three-asset immunology pipeline.

AI can generate words that sound like empathy, but it cannot offer the understanding that a real person can.

David Hung, CEO of Nuvation Bio, details the company’s ongoing trials for new drugs and new indications for existing molecules.

In today's Pharmaceutical Executive Daily, FDA approves Merck's Lipfendra as the first oral PCSK9 inhibitor for high cholesterol, Eli Lilly agrees to acquire AtaiBeckley for up to $3.8 billion, and a Pharmaceutical Executive podcast explores how better questions, not just more data, define strong biopharma leadership.

FDA has approved Merck's Lipfendra as the first oral PCSK9 inhibitor, giving patients with high LDL cholesterol a once-daily pill alternative to injectable therapies.

Ken Banta and Craig Tooman on why the best leaders win by asking better questions — not just chasing more data — and what that means for drug development, funding and AI in the years ahead.
























