Regulatory

Aprecia’s president and COO discusses the impact 3D printing technology is having on drug development, along with the benefits and challenges of being a company that is 100-percent US-based for its manufacturing.

The FDA has approved Ibrance (palbociclib) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.

In today's Pharmaceutical Executive Daily, the FDA announces Operation TrialBlazer, a pilot program aimed at cutting early-stage clinical trial timelines by six to 12 months as the US looks to reclaim its footing in global clinical research, market access expert Manasi Salgaonkar explains why Class of Trade classification is becoming one of the hardest — and most consequential — problems in pharmaceutical commercial operations, and Pharmaceutical Executive speaks with Kyle Smith, president and COO of Aprecia Pharmaceuticals, on how DARPA's EQUIP-A-Pharma program is using federal investment to incentivize the reshoring of drug manufacturing to the United States.

FDA plans a pilot to shorten early-stage drug trial timelines, raising strategic questions for biopharma development and investment.

FDA advisory panel voted 9-0 to recommend approval of Moderna's mRNA flu vaccine mRNA-1010 across both the 50-to-64 and 65-and-older age groups, a unanimous outcome that validates the underlying clinical data.

FDA has expanded Capvaxive's indication to high-risk children and adolescents aged 2 through 17 who have completed a primary pneumococcal series, making it the only conjugate vaccine in the U.S. specifically studied and approved for this population.

FDA has approved Utebzi as the first oral carbapenem antibiotic for complicated urinary tract infections, giving patients and providers an alternative to intravenous-only carbapenem therapy.

Novavax’s EVP of corporate affairs and head of its Sweden division discusses new vaccine technologies, such as its adjuvant matrix technology, are bringing new players into the space.

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.

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.

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.

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.