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
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
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
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
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
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,
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-
Drugs
A newly issued safety update from FDA concludes that the risks associated with AstraZeneca’s Andexxa now outweigh its clinical benefits and calls on the company to withdraw the drug from the U.S. market by the end of the month. Andexxa was granted accelerated approval in 2018 as a
Drugs
FDA has cited SCA Pharmaceuticals for multiple deficiencies in sterile drug manufacturing practices following a 10-day inspection of the company’s outsourcing facility in Little Rock, AR, according to a just-released Form FDA-483. The 10/20-30 inspection raised concerns about microbiological controls, aseptic processing, and the
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad produced by Bristol Myers Squibb’s Karuna Therapeutics unit for its Cobenfy (xanomeline and trospium chloride) capsules, for oral use, is false or misleading. A 12/15 Notice of Violation describes the ad and says its claims and