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As FDA complete response letters continue to impact nearly half of cell and gene therapy submissions, manufacturing strategy and process design are emerging as the industry’s most persistent regulatory vulnerabilities.

With recent leadership shakeups, many are wondering how FDA will change its approach to regulating DTC pharma advertisements.

In today’s Pharmaceutical Executive Daily, Harpreet Singh discusses the evolving regulatory landscape for biopharma, the World Health Organization identifies three priority treatment candidates for the Bundibugyo strain of Ebola virus disease, and this week’s pharma roundup highlights new findings on Mounjaro and long COVID-related immune system changes.

WHO identifies experimental therapies from Mapp Biopharmaceutical, Regeneron, and Gilead as leading candidates for the Bundibugyo strain of Ebola virus disease, as the agency pushes for urgent clinical trials amid a growing outbreak.

Research published this week highlights tirzepatide outperforming other GLP-1 therapies in early type 2 diabetes treatment while separate studies identified autoantibodies as a likely biological driver behind persistent neurological symptoms in some long Covid patients.

Former chief counsel for FDA Dan Troy explains why there is no firm timeline for regulatory reform or update at FDA for DTC pharma advertisements.

In today’s Pharmaceutical Executive Daily, an FDA advisory committee weighs recommendations for the composition of the 2026–2027 Covid-19 vaccines, CVS Health restores coverage for Eli Lilly’s Zepbound while adding the company’s newly approved obesity pill Foundayo, and experts discuss how treatment expectations are evolving in lupus care.

CVS Health is restoring coverage of Eli Lilly’s Zepbound and adding oral obesity drug Foundayo to its formulary, signaling shifting payer dynamics as lower-cost GLP-1 therapies expand access for patients.

FDA advisors are set to meet this week to determine whether Covid-19 vaccines should be updated to target the emerging XFG variant, a decision that could shape the composition of the 2026–2027 immunization season amid ongoing viral evolution.

The Lupus Research Alliance’s CEO and president discusses how recent treatment breakthroughs are changing the patient experience in Lupus treatment.

Harpreet Singh, former FDA Oncology Division Director and current chief medical officer at Precision for Medicine notes how evolving FDA review standards, expedited approval programs, and emerging AI tools are reshaping the regulatory landscape for biopharma companies.

Former FDA chief counsel Dan Troy discusses the motivation behind potential DTC pharma ad bans.

Harpreet Singh, MD, notes that FDA’s internal AI system could improve efficiency in drug review by helping reviewers aggregate and synthesize complex data.