FDA Policy/General
FDA’s latest enforcement action against a schizophrenia drug advertisement offers a pointed reminder of how narrowly the agency continues to interpret permissible direct-to-consumer claims, according to regulatory attorneys reviewing the case. A 12/15 Notice of Violation letter describes the TV ad produced by Bristol Myers Squibb’
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has issued BeOne Medicines USA an untitled letter over its promotional materials for cancer immunotherapy Tevimbra (tislelizumab-jsgr), citing omissions of risk information and an overly broad portrayal of the drug’s approved uses. FDA says said it reviewed two branded Microsoft
Drugs
Representatives of FDA and the drug industry made progress on PDUFA 8 negotiations on real-world evidence (RWE) and first-cycle reviews at the 12/9/2025 FDA/Industry Premarket Subgroup session. According to the meeting minutes, on real-world evidence FDA recommended that the pilot be continued in PDUFA
FDA Policy/General
A new analysis from Harvard Law School argues that the U.S. drug regulator’s reliance on industry-paid user fees has left the agency vulnerable to both corporate influence and political interference, undermining the rigor of drug approvals and potentially putting patients at risk. In a blog post published
Biologics
With all the staffing turmoil FDA went through in 2025, drug and biologic approvals dropped below totals in the previous two years. A Fierce Pharma analysis finds that there were 46 novel drug approvals in 2025, compared to 55 in 2023 and 50 in 2024. In addition, there were 18
Drugs
GSK says its investigational bepirovirsen met the primary endpoints in the B-Well 1 and B-Well 2 pivotal Phase 3 trials evaluating it as a treatment for chronic hepatitis B in over 1,800 patients. A company statement says GSK plans global regulatory filings from the first quarter of
Drugs
FDA has notified Vanda Pharmaceuticals that its sNDA for Hetlioz (tasimelteon) to treat jet lag disorder cannot be approved in its present form. A company statement says the agency acknowledged positive efficacy from the company’s clinical trials, but said the data do not provide substantial evidence of efficacy for
Drugs
Moonlake Immunotherapeutics says it plans to submit a BLA to FDA in the second half of 2026 for sonelokimab to treat hidradenitis suppurativa. A company statement says the decision to move forward followed a successful Type B meeting with FDA that confirmed that the company may establish substantial evidence of
Drugs
In a significant policy shift aimed at modernizing federal oversight of digital health technologies, FDA commissioner Marty Makary is promoting limited regulatory scrutiny of many wearable devices and software tools, especially those that provide general wellness information rather than medical diagnoses or treatment guidance. The move, outlined by Makary’s
Drugs
FDA says the Abiomed 6/23/2025 correction updating the use instructions for its Automated Impella Controllers is Class 1. An agency statement says the company informed affected customers that an Automated Impella Controller may not detect an Impella pump when connected. Abiomed recommended having a backup Automated Impella Controller
Drugs
FDA says its review of the Web site and social media accounts maintained by Agebox, Inc., in Wilmington, DE, determined that it offered iKids-Growth products for sale in the U.S. A 12/19/2025 Warning Letter says FDA obtained samples of the iKids-Growth products and determined that
Drugs
A 4/22-4/24/2025 FDA inspection at the Absolutely Natural drug manufacturing facility in Melbourne, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/30/2025 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy or
Drugs
FDA has released the form FDA-483 issued following a 10/27-10/31/2025 inspection at the Lonza Guangzhou Pharmaceutical active pharmaceutical ingredient manufacturing facility in Nansha District, Guangzhou, Guangdong, China. The three specific inspection observations were: * failure to fully follow responsibilities applicable to the quality unit; * failure to
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer connected TV broadcast ad for Esperion Therapeutics’ Nexlizet (bempedoic acid and ezetimibe) tablets for oral use is false and misleading. A just-released 12/19/2025 Notice of Violation says the ad’s claims and presentations falsely
Drugs
A petition submitted to FDA by Sarfaraz Niazi, described online as an academic biopharmaceutical expert, calls on the agency to adopt a formal guidance or incorporate into an existing guidance a risk-based regulatory framework for peptide therapeutics. The petition also calls on FDA to: * clarify that approval of an
Devices
Among the topics discussed at the 12/11/2025 FDA/Industry MDUFA 6 Reauthorization Meeting were the FDA perspective on reauthorization involving real-world evidence (RWE) and the agency’s perspective on reauthorization of the 510(k) total time to decision (TTD) goal and methodology. According to the meeting minutes,
Drugs
FDA has released the form FDA-483 with nine observations from an 11/10-11/11/2025 inspection at the Pharmathen International drug manufacturing facility in Rodopi, Evrou, Greece. The specific violations were: * failure to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be
Drugs
FDA has issued a complete response letter to the Outlook Therapeutics BLA for ONS-5010/Lytenava (bevacizumab-vikg), indicating that the agency wants to see more confirmatory evidence for the drug as a treatment for wet age-related macular degeneration (wet AMD). A company statement says FDA noted in its
Drugs
FDA has accepted for filing and granted a priority review to Axsome Therapeutics’ sNDA for AXS-05 (dextromethorphan HBr and bupropion HCl) to treat Alzheimer’s disease agitation. The agency set 4/30 as the target PDUFA action date. A company statement says the agency previously granted breakthrough therapy designation
Biologics
Mainstream media stories at the end of 2025 focused on the ongoing controversy over vaccines brought about by recommendations from CBER director Vinay Prasad and newly-appointed CDER director (the fifth director in 2025) Tracy Beth Hoeg. The Guardian reports that Hoeg’s appointment “could signify a closer partnership between
Drugs
FDA has issued a complete response letter (CRL) for Sanofi/Genzyme’s tolebrutinib NDA to treat non-relapsing secondary progressive multiple sclerosis (MS) in adults. The just-released CRL says the agency rejected the submission due to an unusually high risk of severe drug-induced liver injury (DILI) and uncertainties
Drugs
FDA has cited inspection findings at Dr. Reddy’s Laboratories’ Srikakulam, Andhra Pradesh, India, manufacturing facility, flagging a range of quality-control, testing, and manufacturing deficiencies that could affect drug products shipped to the U.S. market. In a seven-page Form FDA 483 issued 12/12 following an inspection