Regulatory

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.

Harpreet Singh, MD, touches on how the Commissioner’s National Priority Voucher program is accelerating regulatory review timelines without fundamentally changing how pivotal trials are designed.

FDA approves AstraZeneca and Daiichi Sankyo’s Datroway for first-line metastatic triple-negative breast cancer, expanding treatment options for patients ineligible for PD-1/PD-L1 inhibitor therapy.

Jeffrey Taubenberger’s departure was announced by Senator Baldwin during a congressional hearing.

MedicNova’s chief business officer details how changes at FDA are causing tension with the industry and investors, who are finding themselves less confident in the regulatory process.

Harpreet Singh, MD, notes that the FDA’s broader shift toward accepting single pivotal trials reflects an evolution in regulatory thinking, while noting the agency still weighs disease severity, unmet need, trial design, and long-term safety

David Crean, chief business officer at MedicNova, highlights bifurcation in regulatory processes at FDA.

FDA undergoes leadership upheaval, leaving key drug and biologics divisions under interim control and raising concerns over regulatory continuity amid turnover at the agency’s highest levels.

FDA approved Baxfendy for adults with uncontrolled hypertension, introducing a new drug class in a large and competitive market.

FDA expanded Enhertu (trastuzumab deruxtecan) use in early HER2-positive breast cancer based on phase 3 neoadjuvant and adjuvant trial data.