Drugs
FDA has issued a proposed a rule that would modernize drug establishment registration requirements by creating a streamlined pathway for distributed manufacturing facilities and clarifying registration obligations for certain foreign drug manufacturers, including active pharmaceutical ingredient (API) makers. The proposal is intended to reduce administrative burdens for companies using advanced
Drugs
Hengrui Pharma and Elevar Therapeutics have received a third FDA complete response letter (CRL) for their combination of camrelizumab and rivoceranib for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC), with the agency again citing manufacturing deficiencies rather than concerns about the therapy's clinical performance. The
Drugs
FDA has resumed posting complete response letters (CRLs) just days after HHS confirmed that new rejection letter releases had been halted temporarily (see story) while the agency reviewed legal and policy concerns surrounding its controversial transparency initiative. The CRL postings, which were launched under former FDA commissioner Marty Makary as
Drugs
FDA has approved a new subcutaneous formulation of Sanofi's anti-CD38 monoclonal antibody Sarclisa (isatuximab-irfc), allowing the therapy to be administered using an on-body injector across all currently approved U.S. indications for the intravenous version of the drug. The newly approved product, marketed as Sarclisa
Drugs
An FDA inspection of SGS North America's contract testing laboratory identified significant concerns with the firm’s laboratory controls, including a failure to adequately verify reference standards used to test pharmaceutical products, according to a Form 483 issued at the close of a March inspection. The inspection was
Drugs
FDA has expanded the indication for Merck's Keytruda (pembrolizumab), including its subcutaneous formulation Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), in combination with Astellas Pharma's Padcev (enfortumab vedotin-ejfv) for treating muscle-invasive bladder cancer (MIBC). The approval extends the regimen's use beyond patients
Drugs
FDA has granted Fast Track designation to Arialys Therapeutics’ ART5803, described as the first precision therapeutic candidate in development to treat anti-NMDA receptor encephalitis (ANRE). A company statement says FDA also has granted the drug orphan drug and rare pediatric disease designations. The company says its scientists used crystallographic
Drugs
FDA’s two primary medical product review centers continued to experience net workforce losses through the first nine months of fiscal year 2026, although hiring improved during the third quarter, according to newly released agency staffing data. The data, published by FDA as of 6/30, show that CDER and
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AstraZeneca and Ionis Pharmaceuticals are reporting that their Phase 3 CARDIO-TTRansform trial evaluating Wainua (eplontersen) in patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) failed to meet its primary efficacy endpoint, marking a setback for the companies' effort to expand the drug's use beyond hereditary ATTR
Drugs
The 303 drug Warning Letters that FDA issued in 2025 were an increase of 59% over the 190 letters it issued in 2024, according to a Krieger Scientific analysis, and early figures for 2026 indicate the trend will continue. The life sciences consulting firm says the surge in Warning Letters
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The House Energy and Commerce Committee's Subcommittee on Health has announced a 7/15 hearing to examine how FDA can help strengthen the nation's leadership in biomedical innovation as lawmakers begin laying the groundwork for the next reauthorization of the agency's user fee programs.
Drugs
Two former FDA officials have submitted a petition asking the agency to convene an advisory committee to consider drug products with clinically meaningful central anticholinergic (antimuscarinic) activity. The petition, submitted by Drs. Andrew Mosholder and Marc Stone says the review is needed “in light of the accumulated evidence that prolonged
Drugs
Former FDAer David Gortler, who is now a Heritage Foundation senior research fellow, sees a correlation between the increasing number of drug and medical device recalls in the last few years and a change in the way the agency approaches facility inspections. Writing in an online Independent Institute news article,
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FDA has released the form FDA-483 with eight observations from a 4/13-4/24 reinspection at the Catalent Indiana sterile drug manufacturing facility in Bloomington, IN. The specific observations were: * failure to always include the conclusions and follow-up in written records of investigations into the failure of
Drugs
FDA has sent Amphastar Pharmaceuticals subsidiary International Medication Systems a Warning Letter citing current GMP violations at its South El Monte, CA drug manufacturing facility. In a Securities and Exchange Commission filing, Amphastar says the 7/2 letter stems from an FDA inspection conducted back in December. At the conclusion
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A sweeping package of FDA initiatives unveiled under HHS’s Operation TrialBlazer (see earlier story) could significantly shorten drug development timelines and reduce regulatory burdens for sponsors, although many of the proposals remain in their early stages, according to a new legal analysis from the law firm Ropes & Gray.
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Responding to an FDA Request for Comments on the Commissioner’s National Priority Voucher pilot program, some stakeholders call for it to continue, perhaps with some changes. In contrast, others say it should be paused. In its response, Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports continuation of
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FDA has temporarily suspended its controversial practice of publicly releasing Complete Response Letters (CRLs) for rejected drug applications while it evaluates the policy and works to establish a formal regulatory framework governing the disclosures (see earlier story). The pause, according to Fierce Biotech, follows the submission of a Covington &
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FDA says its 2/27 review of the Web site maintained by LyfeUnit found that the company is marketing in interstate commerce misbranded and adulterated ketamine products. A 6/23 Warning Letter says the agency has identified significant risks with unapproved ketamine products, especially in the absence of appropriate medical
Drugs
With FDA using its artificial intelligence (AI) tool ELSA during inspections, regulated companies can better prepare for inspections by using their own AI tool. That’s the view of former FDAer David Elder. Writing in a Med Device Online guest column, Elder says using ELSA enables an FDA investigator to
Drugs
FDA has released the form FDA-483 with three observations from a 4/20-5/04 inspection at the QuVa Pharma outsourcing facility in Sugar Land, TX. The specific inspection observations were: * failure to establish and follow written procedures to prevent microbiological contamination of drug products purporting to be sterile;
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FDA has granted Vera Therapeutics an accelerated approval for Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A (IgA) nephropathy who are at risk of disease progression, providing a new treatment option for patients with the chronic kidney disease. The once-weekly subcutaneous injection’s approval was