Drugs
FDA is preparing to roll out a new bonus program that will reward drug and biologic reviewers for completing high-quality drug reviews ahead of schedule, in a bid to accelerate regulatory decisions, according to a Bloomberg news report. According to an FDA official, the incentive program will provide quarterly
FDA Policy/General
FDA says its ability to uphold the “gold standard” of regulatory review depends as much on protecting confidential information as it does on scientific rigor. In a recent FDA Voices post, FDA chief operating officer Barclay Butler says the agency operates at a “unique crossroads” between transparency and confidentiality. While
Drugs
A leading rare disease advocacy group on Thursday urged lawmakers to increase oversight of the Food and Drug Administration, warning that inconsistent use of regulatory flexibility and a drop in advisory committee meetings are creating uncertainty that could delay life-saving therapies. Testifying before the U.S. Senate Special Committee
Drugs
FDA has approved a Sanofi and Regeneron Pharmaceuticals BLA supplement for Dupixent (dupilumab) and its use for treating adults and children ages 6 and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery, marking the first therapy specifically for the condition. Allergic fungal rhinosinusitis is
Devices
FDA has issued an early alert about a potentially high-risk problem involving certain heart pump components manufactured by Abiomed, warning that a malfunction could lead to pump failure and patient death. The alert concerns specific Generation 1 Impella Purge Cassettes and Impella RP Pump Sets used with the company’
Drugs
CDER Division of Applied Regulatory Science (DARS) has published its 2025 Annual Report, highlighting significant research advances, collaborative scientific efforts, and regulatory science initiatives aimed at improving public health and regulatory decision-making. According to the report, DARS completed numerous applied research projects this year, advancing scientific understanding in several
Drugs
Marking Rare Disease Week, Rep. Josh Gottheimer (D-NJ) has introduced five bipartisan bills to help find cures. A media release says the bills are: * Gwenn’s Law (in honor of Gottheimer’s mother, who died due to sarcoidosis) to increase the number of women in clinical trials for rare
Drugs
CDER has published a list of 81 new and revised guidances it plans to issue in this calendar year. The largest number of guidances in one category is 24 on aspects of generic drugs. The guidance categories and number of guidances in each category are: * administrative/procedural (8) * biosimilars (5)
Drugs
A 7/30-8/12/2025 FDA inspection at the AQ USA drug manufacturing facility in Lynden, WA, doing business as Ross Healthcare, identified five significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/12 Warning Letter notes that the company operates a drug manufacturing
Biologics
FDA has accepted for review a Vanda Pharmaceuticals BLA for imsidolimab, a potential new treatment for generalized pustular psoriasis (GPP), a rare and life-threatening autoinflammatory skin disorder. The agency has set a review action target date of 12/12. GPP is characterized by sudden flares of widespread pustules, red
Devices
Fresenius Kabi has recalled (Class 1 device correction) its Ivenix Large Volume Pump due to a software issue. The recall applies to the Ivenix devices version 5.10.1 and earlier. Fresenius has instructed customers to update to software version 5.10.2 as soon as possible. According to an
Drugs
FDA has granted Array BioPharma a traditional approval for its previously accelerated-approved Braftovi (encorafenib) for use in combination regimens to treat certain patients with metastatic colorectal cancer (CRC). Encorafenib previously received accelerated approval in 2024 in combination with cetuximab and mFOLFOX6 for previously untreated metastatic CRC with a BRAF
Drugs
Novo Nordisk says its investigational triple agonist UBT251 demonstrated up to 19.7% mean weight loss after 24 weeks in a Phase 2 trial in China, adding a new entrant to the intensifying race for next-generation obesity drugs. UBT251, a once-weekly injectable peptide targeting the receptors for GLP-
Drugs
FDA has granted Immedica Pharma an accelerated approval for its BLA for Loargys (pegzilarginase-nbln), the first therapy specifically designed to lower plasma arginine in patients with Arginase 1 Deficiency, a rare and progressive metabolic disorder. The action allows Loargys to be used to treat hyperargininemia in adults and children
Drugs
FDA has issued Beta Bionics a Warning Letter, citing wide-ranging quality system, complaint handling, reporting, and recall-related violations tied to the company’s iLet Bionic Pancreas System. The 1/28 letter follows a 6/25 inspection of the company’s Irvine, CA facility, concluding that the company’s
Biologics
After failing to find a buyer, BioMarin has decided to voluntarily withdraw from the market its Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating adults with severe hemophilia A without antibodies to adeno-associated virus serotype 5. Since its 2023 approval, Roctavian failed to achieve commercial success due to low
Devices
The medical device industry is urging federal health officials to keep FDA at the center of oversight for artificial intelligence tools used in patient care, warning that new or duplicative regulatory frameworks could slow innovation and delay access to AI-enabled technologies. In a comment letter responding to a federal
Drugs
FDA has issued a Warning Letter to London-based drug manufacturer A. Nelson & Co. Ltd., citing significant current good manufacturing practice violations and raising concerns about microbiological testing and data integrity at the company’s facility. The 2/12 letter said an unannounced inspection conducted 9/2025 at the
Biologics
Johnson & Johnson has submitted a supplemental BLA seeking approval of Imaavy as a treatment for warm autoimmune hemolytic anemia (wAIHA), a rare and potentially life-threatening blood disorder that currently has no FDA-approved therapies. The drug was approved by FDA 4/2025 for generalized myasthenia gravis in patients
Drugs
FDA has issued a draft guidance entitled Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause. It is intended for sponsors seeking approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized
Drugs
FDA has approved AstraZeneca’s Calquence (acalabrutinib) for use in combination with AbbVie and Genentech’s Venclexta (venetoclax), a chemotherapy-free regimen for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), clearing their use as an initial treatment option. The approval is based on results from the
Drugs
Novo Nordisk says its experimental obesity drug CagriSema delivered substantial weight loss in a head-to-head late-stage trial but failed to meet its primary objective of proving it was not inferior to Eli Lilly’s rival therapy tirzepatide (Zepbound and Mounjaro). In the 84-week Phase 3 REDEFINE