FDA actions, approvals, policy shifts and compliance: how the rules change timelines and probability.
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Mar 2, 2026The path to approval for gene therapies is complex, as seen in UniQure’s experience with AMT-130. After critical remarks from FDA Commissioner Marty Makary, UniQure learned from the FDA that additional rigorous clinical trial design, including sham surgery controls, is necessary before regulatory approval can be pursued.
Daniel Cho
Mar 2, 2026The expiration of several most-favored nation (MFN) drug pricing deals established during the Trump administration marks an inflection point for pharmaceutical manufacturers and healthcare payers. Meanwhile, the 340B drug discount program remains under scrutiny for its financial flows and impact on healthcare providers. These developments underscore evolving challenges in drug pricing and policy in the U.S. healthcare ecosystem.
Daniel Cho
Mar 2, 2026This month, stakeholders in the pharmaceutical and medical communities are focusing on the Food and Drug Administration's (FDA) pending decisions, which were delayed from 2025. These delays affect potential therapies addressing a rare form of obesity and dry eye disease, signaling complexities involved in regulatory evaluations for these conditions.
Dr. Priya Nandakumar
Feb 28, 2026Novartis has become the second major pharmaceutical company to resolve legal claims concerning their use of the HeLa cell line, derived without consent from Henrietta Lacks, an African American woman whose cells have had extraordinary scientific impact. This blog explores the background, settlement implications, and wider ethical and societal consequences.
Michael Torres
Feb 28, 2026In February 2026, the Centers for Disease Control and Prevention (CDC) announced the addition of two new experts to its Advisory Committee on Immunization Practices (ACIP) following rescheduling of a recent meeting. This move reflects efforts to reinforce oversight and expert input on vaccines as the nation navigates updates in vaccine schedules and public health priorities. The CDC’s advisory committee plays a pivotal role in evaluating vaccines and shaping immunization policies nationwide.
Emily Carter
Feb 27, 2026Recent changes by the Centers for Disease Control and Prevention (CDC) to the national vaccine schedule have sparked state-level opposition that threatens to disrupt the market for vaccines produced by industry leaders such as Pfizer, Moderna, and Merck. Legal experts believe manufacturers may adopt a cautious stance rather than actively oppose the revised schedule through litigation.
Emily Carter
Feb 27, 2026A probe into allegations against Vinay Prasad, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), focuses on accusations of creating a hostile work environment. The investigation reflects broader questions about leadership accountability and workplace standards within the agency.
Sophia Reynolds
Feb 27, 2026The FDA's pilot program utilizing regulatory vouchers has enabled Boehringer Ingelheim to expand the indication of Hernexeos rapidly. Now approved as a first-line treatment for a challenging subset of lung cancer, this development marks an important advancement in oncology therapeutics and regulatory strategy.
Emily Carter
Feb 26, 2026The regulatory landscape of healthcare is currently under intense scrutiny with significant challenges facing the FDA, alongside complex political dynamics and rapid technological advancements in AI. Understanding these factors is crucial for stakeholders across the biotech and healthcare sectors.
Jonathan Blake
Feb 25, 2026The management of rare diseases necessitates a nuanced regulatory approach that balances the urgency of patient access with the imperative of safety. Sarepta Therapeutics' experience with its drug Elevidys illustrates the challenges and lessons for regulatory frameworks.
Dr. Priya Nandakumar
Feb 23, 2026Bysanti, based on the active metabolite iloperidone of a core compound originally found in Fanapt, marks an important regulatory milestone for Vanda. This approval reflects both the company’s perseverance in drug development and the FDA’s evaluation of unmet needs in psychiatric disorders.
Daniel Cho
Feb 21, 2026The investigation by Nature Medicine into reported inconsistencies in the study raises critical questions about the optimal timing of immunotherapy for cancer treatment and the broader implications for clinical practice and research integrity.
Emily CarterMachine learning, predictive models and computational biology: how AI is changing discovery workflows and probability of success.
Drug development, clinical trials and industry dynamics. What changes timelines, risk and competitive positioning.
Gene therapy, CRISPR, synthetic biology and emerging platforms. Separating what is real from what is hype, and what actually translates.
Where capital is flowing and why the tape moves, across funding rounds, M&A, IPOs and market analysis.
Digital health, diagnostics and medical devices, and the signals that matter for adoption, reimbursement and outcomes.