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
Drugs
Bipartisan legislation has been introduced in the House and Senate to shield certain drug manufacturers who have submitted drug applications to FDA from patent infringement liability, including induced and contributory infringement, based on the submissions and marketing of the approved drug. The Skinny Labels, Big Savings Act (H.R. 6485)
Drugs
A 7/8-7/11/2025 FDA inspection at the Tower Laboratories drug manufacturing facility in Montague, MI, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/23/2025 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy or
Drugs
FDA says a 6/25-7/3/2025 inspection at the LiquidCapsule Manufacturing drug manufacturing facility in Tampa, FL, found repeated significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 12/19/2025 Warning Letter says the five specific inspection observations were: * failure to
Devices
FDA has published two final digital health guidances. The first, General Wellness: Policy for Low Risk Devices, clarifies CDRH’s compliance policy for low-risk products that promote a healthy lifestyle. The document does not apply to products regulated by other FDA Centers or to combination products. The guidance includes
Drugs
Alumis says its oral tyrosine kinase 2 inhibitor envudeucitinib delivered high levels of skin clearance in two pivotal Phase 3 trials in moderate-to-severe plaque psoriasis, which would position the drug among the most effective next-generation oral therapies for the disease. The company reports that both Phase 3
Devices
FDA says the Dexcom 9/18/2025 software correction for its Dexcom G6 and G6 Pro continuous glucose monitoring software is Class 1. An agency notice says the notice only affects users of version 1.15.0 of the Android U.S. app. The notice says Dexcom made the correction
Devices
FDA is announcing a 1/14 town hall to discuss its Quality Management System Regulation (QMSR), particularly how it addresses medical device risk management, risk-based approaches, risk-based decisions, and design and development. The Medical Devices Quality System Regulation Amendments final rule was published on 2/2024, with an
Drugs
FDA has released a list of 13 potential signals of drug serious risks/new safety information identified by the FDA Adverse Event Report System between 7/2025 and 9/2025. The agency says it is evaluating the need for regulatory action in 10 of the signals. An FDA Safety Communication
Drugs
Minutes from the 12/2/2025 meeting of the PDUFA Reauthorization FDA and Industry Premarket Subgroup show the two sides debated metrics on agency first-cycle review times and goals. At an earlier meeting, industry representatives had presented data supporting their Facilitate First Cycle Review proposals. Session minutes show that
Drugs
FDA has published a guidance, Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act, with recommendations on the formal dispute resolution and administrative hearing procedures for resolving scientific and/or medical disputes between CDER and requestors and sponsors
FDA Policy/General
These are the most substantive Warning Letters FDA issued in the last two weeks of December 2025. Darmerica. A 3/3-3/19/2025 FDA inspection at the Darmerica drug manufacturing facility in Davie, FL, found significant violations, including deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients
Drugs
FDA has released the form FDA-483 issued following a 9/8-9/19/2025 inspection at the Sun Pharmaceutical Medicare sterile drug manufacturing facility in Halol, Gujarat, India. The three specific violations were: * procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established,
Biologics
At the 12/3/2025 public meeting on the BsUFA 4 reauthorization, several industry representatives presented their recommendations for matters to be considered in the reauthorization negotiations. CMC regulatory expert Fabiola Gomez (Hyman, Phelps & McNamara) outlines the recommendations in her firm’s FDA Law Blog. The Biosimilar Forum urged
Biologics
FDA has set a PDUFA action date of 10/30 for its review of an Inovio BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis (RRP). A company statement says the BLA was filed under the Accelerated Approval pathway. Inovio says the agency acceptance letter
Drugs
FDA says it is exploring a new way to contract directly with venture capital–backed innovators in an effort to possibly speed adoption of emerging technologies and reduce reliance on traditional federal contractors. An agency Request for Information (FFI)is seeking input from venture capital firms on a proposed contracting
Drugs
FDA has released an updated guidance outlining its processes for bioresearch monitoring (BIMO) inspections, which oversee the conduct, reporting, and postmarketing activities of FDA-regulated clinical and nonclinical studies. The guidance clarifies how the agency evaluates compliance, interacts with establishments, and manages electronic records, both domestically and internationally. BIMO inspections
Drugs
The newly established Commissioner’s National Priority Review voucher program, which is intended to accelerate the review of select drug applications, is drawing scrutiny for apparent political interference. The program, which is designed to fast-track certain medicines to patients, has seen unprecedented involvement from White House officials and high-