Drugs
FDA has approved changes to the isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy that it says will minimize the burden on patients, prescribers, and pharmacies while maintaining the safe use of the drug. An agency announcement says the modifications include changes listed in the 11/2023 FDA notification to isotretinoin
Drugs
FDA has issued a Warning Letter to Bio-Medical Pharmaceutical Manufacturing Corporation, citing widespread GMP violations at the company’s Houston facility, including serious deficiencies in sterile drug production, process controls, and laboratory testing. The 2/5 Warning Letter follows an FDA inspection conducted 8/25–29/2025 at the
Drugs
FDA has accepted for priority review a Takeda NDA for TAK-861 (oveporexton) as a potential first-in-class treatment for narcolepsy Type 1. Narcolepsy Type 1 is a rare, chronic neurological disorder characterized by excessive daytime sleepiness and cataplexy, resulting from loss of orexin-producing neurons. The agency has
Biologics
FDA has issued Moderna a refusal-to-file letter on its BLA for an investigational seasonal influenza vaccine mRNA-1010, despite the company’s use of a Priority Review Voucher intended to speed the process. The letter, signed by CBER director Vinay Prasad, cited the company’s choice of comparator
Drugs
FDA has issued Sobi Inc. an untitled letter that cites a direct-to-consumer television advertisement for its myelofibrosis drug Vonjo (pacritinib) because it misbrands the product and violates federal law by making misleading benefit claims and omitting key safety information. The just-posted 2/6 letter from CDER Office
Drugs
A 7/21-7/29/2025 FDA inspection at the Signature Formulations drug manufacturing facility in Phoenix, AZ, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 1/21 Warning Letter says the specific violations were: * failure to perform operations within specifically
Biologics
FDA has cited Lonza Portsmouth for significant manufacturing and quality control deficiencies at its New Hampshire cell therapy facility, raising concerns about aseptic processing, environmental controls, documentation practices, and deviation management related to the production of Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy Casgevy. FDA investigators conducted the inspection
Drugs
FDA’s recent decision to reject a low-dose atropine treatment for pediatric myopia — despite a large clinical trial meeting pre-specified safety and efficacy benchmarks — has renewed debate over regulatory standards, evidentiary thresholds, and predictability in pediatric drug approvals, according to a Washington Post opinion article. The action was
Drugs
Faced with mounting criticism of the Commissioner’s National Priority Voucher (CNPV) Pilot Program, focusing on the potential safety risks from quicker reviews, questions about possible politicization and favoritism, legal and transparency concerns, and the strain placed on agency resources and staff, FDA has published a news release with 18
Drugs
An FDA Bioresearch Monitoring Program 10/23-11/8/2024 inspection of two clinical investigations conducted by Mark Dacey in Denver, CO, found that Dacey failed to obtain informed consent for the investigations. A 2/2 Warning Letter acknowledges the corrective and preventive actions the site has taken and plans
Devices
Minutes from the 1/21 MDUFA 6 reauthorization meeting indicate progress is being made in several areas. The minutes say industry representatives gave their feedback on real-world evidence (RWE), saying they support the National Evaluation System for Health Technology (NEST) and emphasizing that NEST Mark is potentially an important
Drugs
FDA has issued two enforcement “untitled” letters to Argenx, alleging that separate direct-to-consumer television advertisements for Vyvgart Hytrulo violate federal drug promotion rules by overstating benefits, minimizing risks and misleading viewers about how the drug is used. In letters sent by CDER’s Office of Prescription Drug Promotion
Drugs
Aurobindo Pharma is reporting that FDA has completed an inspection of wholly owned subsidiary Eugia Pharma Specialities in Pashamylaram, Telangana, India that resulted in 11 procedural observations. The inspection focused on Unit III, Eugia’s formulations manufacturing facility, from 1/27 to 2/6. The latest inspection comes on the
Drugs
FDA has formally told Novo Nordisk that a new direct-to-consumer (DTC) television ad for the newly launched Wegovy (semaglutide) oral weight-loss pill contains claims that could be “false or misleading,” placing fresh regulatory scrutiny on one of the pharmaceutical industry’s highest-profile product launches. In a
Drugs
FDA has issued Regenxbio a complete response letter (CRL) on its BLA seeking accelerated approval for RGX-121 (clemidsogene lanparvovec), a one-time gene therapy for Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome. In the CRL, FDA cited several concerns, including uncertainty in defining the neuronopathic patient population,
Drugs
The Alliance for Pharmacy Compounding (APC), representing both state-licensed compounding pharmacies and FDA-registered outsourcing facilities, has petitioned FDA asking that it reverse its classification of desiccated thyroid extract (DTE) as a biologic product. Under current FDA guidance, DTE products — which contain thyroglobulin from porcine or bovine thyroid tissue
Devices
FDA has cleared a Median Technologies 510(k) for eyonis LCS, the first artificial intelligence (AI)–based device cleared for both detection and diagnosis in lung cancer screening. The software-as-a-medical-device is designed to help clinicians identify lung cancer at earlier, potentially curable stages while reducing false
Drugs
FDA drug regulators and pharmaceutical industry representatives reached a partial agreement last month on several policy proposals under negotiations for the next reauthorization of the Prescription Drug User Fee Act (PDUFA), while leaving other issues unresolved for further talks. According to just-released meeting minutes from a 1/8 session
Biologics
The Biotechnology Innovation Organization (BIO) has submitted detailed comments to FDA recommending broader application of its draft guidance on “Monoclonal Antibodies (mAbs): Streamlined Nonclinical Safety Studies.” The comments highlight ways the agency could reduce animal testing while maintaining rigorous safety standards. BIO praised FDA for emphasizing the 3R principles — replace,
Drugs
Hims & Hers has abruptly shelved its GLP‑1 weight-loss pill offering and now faces a patent battle with Novo Nordisk, marking a dramatic escalation in the fight over compounded weight‑loss medications. Telehealth provider Hims & Hers confirmed it has stopped offering the compounded semaglutide tablet version of
Drugs
FDA has approved a Kite Oncology labeling update for CAR-T therapy Yescarta (axicabtagene ciloleucel), removing a previous limitation on its use in patients with relapsed or refractory primary central nervous system lymphoma (PCNSL), a rare and aggressive form of non-Hodgkin lymphoma. The decision expands access to axicabtagene ciloleucel
Drugs
FDA is pledging to move quickly against companies that mass-market “illegal copycat drugs” by portraying them as equivalent to FDA-approved medicines, commissioner Marty Makary says in an X social media post, presumably signaling a tougher enforcement posture that rattled investors in telehealth company Hims & Hers Health. Makary’