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
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
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
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
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
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’
Drugs
FDA has granted Sonorous Neurovascular a breakthrough device designation for its BosSTENT, a cerebral venous stent designed to treat debilitating pulsatile tinnitus. BosSTENT is a braided, self-expanding venous stent designed to treat symptomatic cerebral venous sinus stenosis, a condition widely recognized as a major contributor to pulse-synchronous tinnitus,
Drugs
FDA has cited Ipca Laboratories over multiple manufacturing and quality deficiencies following an inspection of the company’s active pharmaceutical ingredient (API) facility in India, according to a just-posted inspection report issued in December. FDA investigators inspected the facility in Palghar, Maharashtra, and documented three significant observations that raise
Drugs
A sweeping federal spending package enacted this week includes two long-sought policy changes for FDA — clarifying the scope of orphan drug exclusivity and easing long-standing regulatory hurdles for generic drug developers. The provisions are included in the Consolidated Appropriations Act of 2026, and reflect years of lobbying by
Drugs
FDA has released the form FDA-483 issued following a 1/5-1/14 inspection at the U.S. Specialty Formulations outsourcing facility in Allentown, PA. The seven inspection observations were: * failure to fully follow the responsibilities and procedures applicable to the quality control unit; * failure to establish and document
Drugs
FDA has published for public comment an International Council for Harmonization draft guideline, General Considerations for Patient Preference Studies E22, with general considerations about the use, design, conduct, analysis, and submission of patient preference studies (PPS) aimed at informing drug development, regulatory submission and evaluation, drug approvals, and maintenance of
Drugs
Bayer is reporting that its investigational oral anticoagulant asundexian reduced the risk of recurrent ischemic stroke by 26% in patients who had recently experienced a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack, without increasing major bleeding. The findings are from the company’s just-reported pivotal