Devices
FDA is alerting healthcare providers to a potentially high-risk issue involving dialysis tubing sets used with Prismaflex systems after manufacturer Vantive warned that a key component may become dislodged during treatment. In an agency early alert, Vantive is said to have notified customers that updated use instructions are needed
Drugs
FDA has lifted a clinical hold against GH Research’s investigational antidepressant GH001, clearing the way for patient enrollment in the U.S. and advancing plans for a global late-stage development program. The action allows the clinical-stage biotechnology company to resume U.S. trials under its IND and
Drugs
FDA has granted Novartis a breakthrough therapy designation to its experimental antibody ianalumab for treating Sjogren’s disease, a move that could speed development and regulatory review for a condition with no approved targeted therapies. The designation was based on clinical data from multiple studies, including replicate Phase 3 trials,
Drugs
Johnson & Johnson is reporting positive results from a late-stage clinical trial showing that its bispecific antibody therapy Tecvayli (teclistamab-cqyv) significantly improved survival outcomes compared with standard treatments in patients with relapsed or refractory multiple myeloma, including those who had failed commonly used therapies. The Phase 3 MajesTEC-
Biologics
Scholar Rock says it is planning to resubmit this year its BLA seeking approval of apitegromab, a first-in-class muscle-targeted therapy for spinal muscular atrophy (SMA). In 9/2025, FDA issued a complete response letter that cited observations made during an FDA inspection of Catalent Indiana, a third-
Drugs
CBER has published a Standard Operating Policy and Procedure (SOPP) on “Administrative Processing and Review Management Procedures for Investigational New Drug Applications.” The SOPP applies to INDs received by CBER, including those for expanded access, except for individual emergency use requests. It does not address the specific content of scientific
Drugs
Strive Specialties, a compounding pharmacy headquartered in Arizona with offices, staff, and customers in Texas, has filed a lawsuit in a Texas federal court, charging that Eli Lilly and Novo Nordisk are violating antitrust laws in their marketing of glucagon-like peptide 1 agonist (GLP-1) drugs, which are indicated
Drugs
FDA has cited Biocon Biologics Limited for a series of manufacturing and quality control deficiencies following an inspection of the company’s drug substance manufacturing facility in Bengaluru, India, according to a just-posted FDA Form 483. The inspection, conducted between 8/26 to 9/3/2025, identified multiple concerns
Drugs
FDA has released the form FDA-483 with eight observations from an 11/10-11/21/2025 inspection at the Shilpa Medicare drug manufacturing facility in Polepally, Jadcherla, Telangana, India. The specific observations were: * failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to
Drugs
Rep. Raja Krishnamoorthi (D-IL), ranking member of the House Select Committee on the Strategic Competition Between the U.S. and the Chinese Communist Party, has written to three Chinese drug companies requesting detailed information about their manufacturing, labeling, and exporting of glucagon-like peptide-1 weight loss drugs and
Devices
FDA has cleared a BD 510(k) for its EnCor EnCompass Breast Biopsy and Tissue Removal System, a new platform designed to allow clinicians to perform breast biopsies across multiple imaging modalities. The company says the device is intended to support the diagnosis of breast disease by giving providers greater
Drugs
FDA has delayed its review of Sanofi’s diabetes drug Tzield (teplizumab-mzwv) and Disc Medicine’s blood disorder medication bitopertin due to safety and efficacy concerns. An exclusive Reuters story says both drugs were being reviewed as part of the new Commissioner’s National Priority Voucher Program, which promised
Drugs
In a significant deal that underscores the rising valuation of regulatory fast-tracks in the biopharma sector, Jazz Pharmaceuticals announced it has sold its FDA Priority Review Voucher (PRV) for $200 million to an undisclosed purchaser. The transaction was disclosed during Jazz’s presentation at the J.P. Morgan Healthcare
Devices
FDA has cleared an iotaMotion 510(k) for an expanded pediatric indication for its iotaSOFT robotic-assisted cochlear implant insertion system, allowing its use in children as young as four years old. The device is designed to standardize and precisely control the insertion of cochlear implant electrodes, a step surgeons
Drugs
Charles River Laboratories has named former FDA principal deputy commissioner Namandjé N. Bumpus as senior vice president and chief scientific and innovation officer. In this role, Bumpus will lead the company’s scientific strategy, oversee research and development initiatives, and advance innovation to support clients in accelerating the drug development
Drugs
FDA has issued an untitled letter to Altor BioScience, an indirect wholly owned subsidiary of ImmunityBio, alleging that promotional Web pages for bladder cancer drug Anktiva (nogapendekin alfa inbakicept-pmln) are false or misleading and violate federal law. In the just-posted letter, CDER’s Office of Prescription Drug Promotion
Drugs
Following several months of collaboration, FDA and the European Medicines Agency have published a document outlining 10 guiding principles for good artificial intelligence (AI) practice in drug development. An FDA statement says the “integration of AI in drug development has the potential to transform the way drugs are developed and
Devices
A 7/18-8/1/2025 FDA inspection at ASP Global, doing business as Anatomy Supply Partners in Austell, GA, found multiple violations in the firm’s manufacturing of the Safe-T-Fill Micro Capillary Collection System. A just-released 12/9/2025 Warning Letter cited these specific Quality System
Drugs
Taxpayers Protection Alliance executive director Ross Marchand uses a Baltimore Sun op-ed column to complain that FDA “has lost its way and shuns innovation.” He writes that as a result, “frustrated Americans are increasingly rebelling against the sclerotic agency by turning to gray and black markets for unproven ‘Chinese
Drugs
A 7/14-8/5/2025 FDA inspection at the Winder Laboratories drug manufacturing facility in Winder, GA, found repeat significant violations of current good manufacturing practice (CGMP) regulations. A 1/7 Warning Letter says the specific violations were: * failure to clean, maintain, and, as appropriate for the nature of
Biologics
FDA has accepted for priority review an Argenx supplemental BLA seeking to expand the use of its myasthenia gravis drug Vyvgart (efgartigimod alfa-fcab) to adults with acetylcholine receptor antibody–negative generalized myasthenia gravis. The agency set a user fee review action target date of 5/10. If approved, the
Drugs
At the end of 2025, FDA removed from its Web site an informational page warning parents about the dangers of bogus autism treatments. An online Ars Technica post says elimination of the page was confirmed by HHS, which said it had been retired as part of a routine cleanup of