Drugs
FDA says it welcomes novel approaches for evaluating psychedelic drugs for mental health conditions, including changes to how the products are studied, administered and monitored over the long term, agency officials said in a New England Journal of Medicine article. The agency's willingness to consider alternative approaches reflects
enforcement
FDA has released the Form FDA-483 issued following a 6/8-6/17 inspection at XeCare, a New Albany, OH, producer of sterile and non-sterile drug products. The three inspection observations were: * producing hazardous drugs without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/
Drugs
FDA has issued a partial clinical hold on Biohaven’s opakalim (BHV-7000) due to “nonclinical characterization of certain metabolites” documented in rodent testing, according to the company. “It was determined that there was insufficient information related to a specific metabolite to assess risks of that metabolite to human subjects
Devices
BMC Medical has recalled (Class 1) its Luna G3 APAP (Model LG3600), an auto-adjusting positive airway pressure machine for treating obstructive sleep apnea, due to a firmware defect. If affected devices operate simultaneously under high pressure, high respiratory rate, and high peak flow, an "Error" message on
Drugs
FDA has granted priority review for a Roche sBLA for Enspryng (satralizumab) to treat myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), an autoimmune disease with no approved treatments. A company statement says FDA is expected to make a decision on the sBLA by 1/10/2027. Roche says acceptance of
enforcement
Former FDA chief counsel Mark Raza has joined Hogan Lovells Cadwalader as senior counsel in its Pharmaceuticals and Biotechnology practice. Raza has more than 35 years of FDA experience, including service in the agency’s Office of Chief Counsel. He retired in 2025 after serving four years as chief counsel.
Drugs
AstraZeneca says data from the Phase 3 OBERON and TITANIA trials showed that tozorakimab is the first biologic to demonstrate statistically significant efficacy in reducing moderate and severe exacerbations in a broad population of patients with chronic obstructive pulmonary disease (COPD) still experiencing exacerbations while on inhaled standard of care.
Drugs
FDA has published the Accelerated Rare disease Cures (ARC) program strategic plan covering 2025-2030. The document outlines the vision, mission, and programmatic goals for the five years. “The plan details the specific outcomes, expected results, and related strategies on which ARC’s leadership and the rare disease community will
Drugs
FDA has granted breakthrough therapy designation to UCB’s Cimzia (certolizumab pegol), a tumor necrosis factor blocker, to prevent placenta-mediated adverse pregnancy outcomes in pregnant women with antiphospholipid syndrome (APS) who are positive for lupus anticoagulant (LA). A company statement says the designation builds on a recent FDA orphan
Biologics
FDA has accepted for review a Nanoscope Therapeutics BLA seeking approval for Mogenry (sonpiretigene isteparvovec, MCO-010), an optogenetic gene therapy designed for vision restoration in patients with retinitis pigmentosa (RP) having severe vision loss. “The strength of our RESTORE data, together with the durability we have observed through long-
Drugs
Rezolute says FDA officials have informed it that the agency is continuing to review data from the company’s Phase 3 sunRIZE study of ersodetug to treat hypoglycemia due to congenital hyperinsulinism (HI). A company update statement says that at a March Type B meeting, agency officials asked Rezolute to
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