Drugs
FDA has granted Bayer accelerated approval for Hyrnuo (sevabertinib), a kinase inhibitor for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. The expanded approval broadens
Drugs
FDA has issued a guidance entitled Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates that is intended to help maintain supplies of starter parenteral nutrition drug products for newborns amid potential supply disruptions following the market exit of the predominant supplier. Starter parenteral nutrition provides premature
Drugs
CDER acting director Michael Davis and CBER acting director Karim Mikhail have both been selected as permanent directors of their respective offices. Davis returned to FDA as CDER deputy director in 2025 after serving as Usona Institute chief medical officer for two and a half years. He left the agency
Drugs
FDA has acknowledged that Bristol Myers Squibb’s (BMS) accelerated approval of Krazati (adagrasib) in combination with cetuximab for adults with previously treated, KRAS G12C-mutated locally advanced or metastatic colorectal cancer has been voluntarily withdrawn by the company. The action was based on a ( xxx delete failed XX)confirmatory
Drugs
FDA has accepted for priority review an Intellia Therapeutics BLA for lonvo-z, an in vivo CRISPR-based therapy for treating hereditary angioedema (HAE). The agency has set a user fee review action target date of 3/10/2027. The BLA is based on data from Intellia’s global Phase
enforcement
FDA has cited Travere Therapeutics over promotional materials for Filspari (sparsentan) because they contain misleading claims about the drug’s ability to preserve kidney function and its safety profile. “Specifically, claims suggesting that patients treated with Filspari will achieve kidney preservation, preservation of kidney function, or nephroprotection are misleading because
Drugs
FDA is soliciting public comment on a proposed study of healthcare providers’ perceived barriers to sufficient patient enrollment in pregnancy exposure registries. A Federal Register notice says human pregnancy safety data are collected post-approval to ensure that pregnancy information in product labeling is accurately communicated to healthcare providers (HCPs)
enforcement
A 1/27-2/5 FDA inspection at the Fenwal International facility in Maricao, PR, documented evidence of significant deviations from current good manufacturing practice (CGMP) requirements applicable to the firm’s manufacture of blood pack units and component solutions intended for the collection and storage of whole blood and
enforcement
A 6/2-6/13/2025 FDA Bioresearch Monitoring Program inspection of a clinical trial conducted by Stephen Fallon in Wilton Manors, FL, found that Fallon violated regulations governing the proper conduct of clinical studies involving investigational products. An 8/27 Warning Letter says the specific violations were: * failure to
Drugs
FDA says it is working with manufacturers to increase supplies of estradiol transdermal patches after reports that some patients are having difficulty finding their usual products at pharmacies. In a 9/3 update, the agency says it is working with all six manufacturers of FDA-approved estradiol transdermal patches to
Devices
FDA’s recent discussion paper (see earlier story) on regulating generative AI (GenAI) medical devices could increase regulatory scrutiny for user-facing GenAI-enabled devices, according to an analysis by law firm Crowell & Moring, which says the agency may need to rethink traditional approaches to evaluating medical software. FDA
Drugs
FDA has approved Ionis Pharmaceuticals’ Zanvastro (zilganersen) injection for treating Alexander disease in pediatric and adult patients — the first approved treatment for the disease and the first therapy to directly target the protein buildup that causes it. The rare, progressive neurological disorder is caused by mutations in the gene that
FDA Policy/General
Opposition to FDA commissioner nominee Heidi Overton is mounting, as a letter-writing campaign is underway to block Senate confirmation over her involvement with the Make America Healthy Again agenda, among other issues. “The FDA regulates the vaccines, medications, medical devices, food and other products Americans rely on every day,
Drugs
FDA has granted AstraZenenca an accelerated approval for Etcamah (camizestrant), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. The approval applies to
Devices
FDA has granted Heartvue.ai a 510(k) clearance (K260811) for its Heartvue.Proton, a machine learning–powered software for viewing, post-processing, and quantitative evaluation of cardiovascular magnetic resonance images (MRI). Cardiac MRI is the gold standard for assessing cardiac structure and function, but manual analysis can take up
Drugs
AbbVie is reporting “positive topline results” from the Phase 3 CERVINO study evaluating etentamig, an investigational BCMA x CD3 bispecific T-cell engager, versus standard available therapies (SAT) in patients with triple-class exposed (proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody) relapsed/refractory multiple myeloma (RRMM). CERVINO met
enforcement
CDRH has issued an early alert based on a Draeger letter to customers recommending certain VentStar Resus Neo hoses (breathing circuits) be removed from where they are used or sold. Draeger stated that they are aware of cases in which obvious cracks in the hose were detected by the users
Devices
Boston Scientific has recalled (Class 1) all unused spinal cord stimulator Infinion CX Leads after determining that the lead body may experience mechanical stress at the anchor site, which may result in high impedance measurements or lead fractures. “Abnormal impedance measurement may lead to inadequate stimulation and/or additional intervention,
FDA Policy/General
Peter Barton Hutt, former FDA chief counsel who was widely known as the "Dean of the Food and Drug Bar," died on 9/2 at the age of 91. Hutt spent more than six decades shaping the legal and regulatory framework governing drugs, medical devices, foods and other
Drugs
The consulting firm RMS says its analysis of over 300 complete response letters (CRLs) posted by FDA since 2025 shows that the most effective strategy for coping with CRL risk is prevention. Writing in the Real Economy blog, RMS says, “Companies that identify and resolve potential regulatory, quality, and manufacturing
enforcement
Senate Special Committee on Aging chairman Rick Scott (R-FL) and ranking member Kirsten Gillibrand (D-NY) are asking the Government Accountability Office (GAO) to analyze the connection between foreign drug manufacturing and drug recalls. In their letter to the GAO, the senators said, “Over the past three decades, the
Drugs
FDA is seeking public input and comments on its efforts to advance the development of botanical drug products (BDPs). A Federal Register notice to be published on 9/4 says the agency wants to “better understand stakeholders’ perspectives on the state of BDP development in the U.S., challenges encountered,