Regulatory

FDA scientists have flagged evidence gaps in Moderna's mRNA flu vaccine mFlusiva ahead of an advisory committee vote, raising questions about its performance across influenza strains, high-risk patient subgroups, and co-administration scenarios.

FDA has approved Skinvive by Juvéderm as the first hyaluronic acid injectable specifically indicated for neck wrinkles, expanding the Allergan Aesthetics franchise into a new anatomical area.

Polaryx’s chief medical officer discusses the regulatory environment for rare, pediatric treatments and how it’s directly impacting clinical trials.

FDA approved two targeted combination regimens this week, clearing AstraZeneca's Truqap as the first biomarker-directed therapy for PTEN-deficient prostate cancer and Merck's Keytruda and Keytruday Qlex plus Welireg.

Silvia Taylor of Novavax discusses the role that regulatory agencies play in vaccine usage, who can receive vaccines, how they’re administered, and under what conditions.

Jazz Pharmaceuticals' Zepzelca failed to improve overall survival in the Phase III Lagoon confirmatory trial for second-line small cell lung cancer, putting its accelerated approval in that setting at risk.

Polaryx’s chief medical officer Lisa Bollinger explains how basket-trials are uniquely beneficial to rare disease therapy development.

Eli Lilly and Company notes that the approval of an every-8-week maintenance dose of lebrikizumab offers sustained atopic dermatitis control with fewer annual injections.

Lisa Bollinger, chief medical officer at Polaryx, discusses signs that regulatory agencies are taking the issues related to rare disease therapy development seriously.

The Supreme Court ruled unanimously in favor of Hikma Pharmaceuticals, finding its generic Vascepa did not infringe Amarin's patents under the skinny-label pathway, a decision that strengthens legal protections for generic manufacturers.

FDA's CBER details a framework for sponsors to apply existing CMC, nonclinical, and clinical data to genome-editing-based product development and regulatory filings.

In today's Pharmaceutical Executive Daily, FDA has accepted a new drug application for giredestrant under priority review, FDA also issues a complete response letter for Cingulate's CTx-1301, and Dan Troy, former FDA Chief Counsel, explains the roadblocks and hurdles facing the FDA's efforts to bring stricter oversight to direct-to-consumer prescription drug advertising.

FDA has accepted Roche's NDA for giredestrant under Priority Review, moving the investigational oral SERD closer to potential approval .

FDA has issued a Complete Response Letter to Cingulate’s ADHD candidate CTx-1301 over manufacturing-related deficiencies, delaying approval of the once-daily therapy while leaving its clinical safety and efficacy profile unchallenged.

Between 2026 and 2030, billions of dollars in revenue will be at risk due to expiring patents and periods of exclusivity.

The former lead counsel discusses FDA’s efforts to bring about strict oversight on DTC drug ads and the difficulties the agency faces in doing so.

FDA approves Shionogi’s Xocova as First Oral Post-Exposure Covid-19 Prevention Therapy, marking a major milestone for Covid-19 prevention treatments.

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.

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.

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.

Dan Troy, former FDA chief counsel, explains limits on what regulations FDA can put on DTC advertisements.

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.

FDA approves Gilead’s Hepcludex as the first treatment for chronic hepatitis delta virus in the U.S., marking a major milestone for a severe liver disease with limited therapeutic options.