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FDA has issued a draft guidance entitled Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known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
Drugs
FDA has appointed a veteran artificial intelligence executive to lead its digital health policy unit, signaling a sharper regulatory focus on AI-driven medical technologies. Rick Abramson, who previously served as chief medical officer at a subsidiary of Harrison.ai, an Australian firm known for developing advanced AI systems designed
Drugs
FDA appears to be sustaining — and in some cases accelerating — its scrutiny of prescription drug advertising months after launching a high-profile enforcement push in 9/2025. The September initiative included 65 Warning and untitled letters issued the same day to biopharmaceutical manufacturers. In the months since, CDER Office of
Devices
Olympus has recalled (Class 1) its high-flow insufflation units, warning that continued use of the devices could cause serious injury or death. An agency notice says a software algorithm in the devices requires correction to address a potential issue that could result in overpressure events during use. Because no
Drugs
FDA has placed a partial clinical hold on a MacroGenics Phase 2 (LINNET) trial of its investigational immunotherapy lorigerlimab, halting enrollment of new patients while allowing those already in the study to continue treatment. MacroGenics says the agency action followed the company’s recent decision to temporarily pause enrollment after
Drugs
Trump 2.0 appears to be changing the FDA approval landscape, and new opportunities and pitfalls abound for defendants seeking to establish a preemption defense. That’s the view of attorney Grant Hollingsworth (Hollingsworth) writing in an online post. Hollingsworth says there are already regulatory pilot programs and deregulatory initiatives
Drugs
FDA has cited significant data integrity and quality control failures at an Indian manufacturing facility operated by Aurobindo Pharma, raising concerns about the reliability of testing records and the oversight of drugs distributed to the U.S. market. The findings, detailed in a just-posted Form FDA 483, follow a
Devices
FDA has accepted a Sibel Health Letter of Intent for its Aria cough monitor into the Clinical Outcome Assessment Qualification Program under the Drug Development Tool framework. A company statement says the Aria sensor adheres directly to the suprasternal notch at the base of the neck and uses advanced acousto-
Drugs
FDA has accepted for review a Genentech NDA for giredestrant, setting up a potential new treatment option for patients with endocrine-resistant breast cancer later this year. The company says it is seeking approval for the therapy’s use in combination with everolimus for adults with estrogen receptor (ER)-positive,
Drugs
A Maryland federal judge has dismissed a physician’s bid to force FDA to create a special, conditional access pathway for certain experimental Alzheimer’s treatments, holding that the doctor lacked standing to sue. Maryland physician Jianyi Zhang sued FDA “on behalf of millions of individuals” with Alzheimer’s disease
Drugs
FDA has accepted for priority review a Savara BLA for Molbreevi as a treatment for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The agency has set a user fee review action date of 8/22. Autoimmune PAP is described as a rare and potentially serious lung disease marked by the accumulation
Drugs
CDER acting director Tracy Beth Hoeg is preparing new safety reviews of widely used antidepressants and monoclonal antibodies for respiratory syncytial virus (RSV), setting up fresh tensions with major medical societies and manufacturers over products many clinicians consider well established. In her first address to staff as acting director, Hoeg
Drugs
Hyloris Pharmaceuticals says a recent FDA inspection of its Greek manufacturing partner resulted in an “Official Action Indicated” designation that could delay approval of its proposed valacyclovir oral suspension product in the U.S. Hyloris says its NDA remains under FDA review, despite a previously assigned review action target date
Devices
A patient safety group has petitioned FDA urging it to rescind or narrow a recent device clearance that allows use of a robotic surgical system in nipple-sparing mastectomy procedures, arguing that long-term cancer outcomes have not been established. The petition asks the agency to immediately amend or withdraw
Drugs
FDA has released the 19-page form FDA-483 with seven observations, including one repeated observation, from an 11/10-11/25/2025 inspection at the Lupin drug manufacturing facility in Verna, Salcette, Goa, India. The specific inspection observations were: * failure to fully follow the responsibilities and procedures applicable to
FDA Policy/General
A new analysis published in JAMA Health Forum examines FDA’s quiet but significant shift in how it seeks outside scientific advice, raising legal and credibility concerns about the agency’s decision-making process. In the article, C. Joseph Ross Daval and Aaron S. Kesselheim contend that FDA has scaled
Drugs
FDA has granted Pilatus Biosciences a fast-track designation for its lead drug candidate, PLT012, for treating hepatocellular carcinoma (HCC). PLT012 is described as a first-in-class monoclonal antibody designed to inhibit CD36, a lipid transporter implicated in metabolic immune suppression within the tumor microenvironment. CD36 is expressed on
Drugs
At a 1/21 GDUFA 4 reauthorization negotiating session, industry representatives offered counterproposals and responses on several topics raised by FDA in previous sessions. Meeting minutes indicate that: * Industry responded to FDA’s counter proposal on invoice timing and indicated FDA’s position would be acceptable, provided the agency ensures