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
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’
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
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
Drugs
FDA is announcing several actions aimed at accelerating the development of treatments for serious mental illness, following a recent executive order from president Trump that directed federal health agencies to expand access to emerging therapies. The measures include new priority review incentives, clearance of early-stage clinical research, and forthcoming
Drugs
A recent FDA Warning Letter is signaling a broader regulatory focus on how drugmakers use artificial intelligence (AI), according to a new analysis by law firm Morgan Lewis. In a 4/24 blog post, the firm said the agency is moving beyond its earlier oversight of AI as a regulated
Drugs
FDA has issued an untitled letter to Incyte Corp., warning that portions of the company’s consumer-facing Web site for Niktimvo (axatilimab-csfr) contain false or misleading promotional claims that violate federal law. CDER’s Office of Prescription Drug Promotion (OPDP) says it reviewed the drug’s branded site,
Drugs
FDA sharply expanded enforcement and oversight activities in 2025, issuing hundreds of Warning Letters and targeting a wave of unapproved and counterfeit drugs — particularly popular weight-loss medications — according to a just-released annual report from CDER’s Office of Compliance. The report outlines a year marked by increased regulatory
Drugs
FDA has issued an early alert warning healthcare providers about a potentially dangerous defect in certain angiographic syringes included in medical convenience kits, citing risks that could lead to serious injury or death. The alert highlights a problem involving syringes distributed by Aligned Medical Solutions and manufactured by Medline Industries.
Drugs
FDA has issued Grace Therapeutics a complete response letter rejecting approval for its experimental treatment GTx-104 (nimodipine), citing outstanding manufacturing and non-clinical issues rather than problems with clinical efficacy. The drug is being developed for intravenous infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage patients.
Drugs
FDA has released the form FDA-483 with five observations from a 3/9-3/27 inspection at Revive Rx, doing business as Revive Rx Pharmacy, a Houston, TX, producer of sterile and non-sterile drugs. The specific repeat inspection observations were: * microbial contamination was present in the ISO 5
Drugs
FDA has released the form FDA-483, with six observations from a 1/27-2/3 inspection at Global Calcium Pvt. Ltd., an active pharmaceutical ingredient manufacturer in Hosur, India. The specific inspection observations were: * failure of laboratory records to include complete data derived from all tests, examinations, and assays
Drugs
FDA commissioner Marty Makary indicated this week that the agency is not planning to eliminate direct-to-consumer (DTC) pharmaceutical advertising, even as it ramps up enforcement against misleading promotions. Speaking at the DTC National conference on 4/21, Makary said the agency does not intend to pursue policies that
Drugs
Two researchers say there are things FDA can do to better use its new plausible mechanism pathway that is expected to increase incentives for drug companies to develop personalized treatments, including gene-editing therapies, for rare disorders. Writing in Nature, the researchers say the bespoke nature of personalized gene therapies