Biologics
FDA has cited significant manufacturing and quality control concerns at a Celgene cell therapy facility in New Jersey, including deficiencies in sterile processing, environmental monitoring, and facility maintenance. The observations were detailed in a just-released FDA Form 483 issued following an inspection conducted last year at the company’s
Drugs
FDA has accepted for priority review a GSK NDA for its investigational hepatitis B treatment bepirovirsen. The agency set a user fee review action target date of 10/26. The investigational antisense oligonucleotide is being developed for adults with chronic hepatitis B, a viral infection that affects more than 250
FDA Policy/General
Insulet has recalled (Class 1) certain insulin pump components, warning that continued use could result in severe injury or death. The recall affects specific lots of the company’s Omnipod 5 Pods, a wearable device used to deliver insulin continuously for people with diabetes. According to an FDA notice, Insulet
Drugs
FDA has released the form FDA-483 issued following a 3/4-3/11/2025 inspection at the Fujifilm Diosynth Biotechnologies Texas drug manufacturing facility in College Station, TX. The eight inspection observations were: * failure to adequately control the multi-product manufacturing areas to prevent potential cross-contamination; * the quality
Drugs
A 9/23-9/29/2025 FDA inspection at the Lexia LLC drug manufacturing facility in Franklin, TN, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/7 Warning Letter says that during the inspection, company officials indicated that they would not continue to
Drugs
A 10/20-10/24/2025 FDA inspection at the Foshan Miwei Cosmetics Co. drug manufacturing facility in Foshan, China, found current good manufacturing practice (CGMP) violations in the firm’s production of misbranded unapproved new drugs. A 4/20 Warning Letter says the specific violations were:, * failure to have
Drugs
A 9/8-9/17/2025 FDA inspection at the Intas Pharmaceuticals Limited drug manufacturing facility in Selaqui, Dehradun, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 3/30 Warning Letter says the specific violations were: * failure to thoroughly investigate any
Drugs
FDA has accepted for priority review a Johnson & Johnson supplemental BLA for Imaavy (nipocalimab-aahu) as a potential treatment for warm autoimmune hemolytic anemia (wAIHA). The rare, potentially life-threatening disorder is caused by immunoglobulin G (IgG ) autoantibodies that target and destroy red blood cells, leading to anemia, the
Drugs
FDA is escalating efforts to prompt Amgen to voluntarily withdraw its autoimmune disease drug Tavneos (avacopan), concluding the therapy lacks reliable evidence of effectiveness and raising serious concerns about data integrity in the application submitted by its subsidiary ChemoCentryx. In February, Amgen pushed back on an earlier FDA request to
FDA Policy/General
FDA is moving to modernize how clinical trials are conducted, unveiling a pair of proof-of-concept studies and outlining plans for a broader pilot program aimed at enabling real-time data sharing between sponsors and regulators. In a 4/28 announcement Tuesday, the agency says two early-stage “real-
Devices
Initial FDA Quality Management System Regulation (QMSR) investigations have shown that agency investigators are likely to verify that connections between complaint handling, unique device identifier assignment and documentation, and post-market surveillance activities are adequately addressed. An online Quality Magazine article says dual compliance is also an inspection focus area,
Drugs
FDA has released the form FDA-483 issued following an 11/12-11/19/2024 inspection at Excelvision, a drug manufacturer in Annonay, Ardèche, France. The five inspection observations were: * failure of written records of investigations into unexplained discrepancies to always include the conclusions and follow-up; * failure of procedures
Drugs
FDA has granted a fast track designation to Scancell’s iSCB1+, the company’s lead ImmunoBody to treat advanced melanoma. A company statement says the designation was based on the Phase 2 SCOPE study in which patients receiving either nivolumab (Bristol Myers Squibb’s Opdivo) plus ipilimumab (Bristol Myers Squibb’
Biologics
FDA is still weighing candidates to lead CBER as controversial director Vinay Prasad prepares to leave the agency at the end of the month. FDA commissioner Marty Makary says a decision is expected “in the coming weeks,” according to reporting from Reuters. Makary had previously indicated a successor would be
Drugs
Rocket Pharmaceuticals says it has agreed to sell an FDA rare pediatric disease priority review voucher for $180 million to support its gene therapy pipeline. The voucher was awarded for gaining accelerated approval for Kresladi (marnetegragene autotemcel). The company now expects its existing cash resources, combined with proceeds from the
Drugs
On Tuesday (4/28), FDA is expected to detail a significant shift in how clinical trials are conducted and regulated, announcing “major steps to implement real-time clinical trials.” According to agency communications and recent public statements, the move signals the clearest indication yet that FDA is preparing to operationalize
FDA Policy/General
Galaxy Therapeutics has submitted the final module of a PMA for its SEAL device, a treatment designed for patients with wide-neck bifurcation brain aneurysms. The filing completes the company’s modular PMA submission, a regulatory pathway that allows device makers to submit sections of an application incrementally. The SEAL
Biologics
Intellia Therapeutics has begun a rolling BLA submission for its experimental gene-editing therapy lonvoguran ziclumeran, or lonvo-z, as a one-time treatment for hereditary angioedema (HAE). The company expects to complete submission in the second half of the year and, if approved, launch the therapy in the first
Drugs
FDA has identified significant deficiencies at BayCare Integrated Service Center, an outsourcing facility in Temple Terrace, Florida, following a March inspection, according to a just-released FDA Form 483. The inspection found weaknesses in environmental monitoring, cleaning validation, quality oversight, and batch release practices that could affect the sterility and
Drugs
FDA has accepted for priority review a Jazz Pharmaceuticals supplemental BLA for Ziihera (zanidatamab-hrii) for use in combination regimens for first-line treatment of patients with HER2-positive advanced gastroesophageal cancers. The agency has set a user fee review target decision date of 8/25. The filing seeks to
Drugs
A federal judge has dismissed a lawsuit brought by homeopathy advocates and a product distributor challenging FDA’s decision to tighten oversight of homeopathic drugs, ruling the plaintiffs failed to demonstrate legal standing. In a memorandum opinion issued by judge Christopher R. Cooper of the U.S. District Court for
FDA Policy/General
Concerns that political pressure could undermine the U.S. drug approval system are intensifying this week after a new White House directive on psychedelic therapies appears to be steering FDA toward accelerated reviews (see earlier story) — prompting warnings from public health experts about risks to scientific integrity. Former FDA associate