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FDA Oncology Chief to Focus on AI, Streamlined Drug Development

Oncology Center of Excellence (OCE) director Angelo de Claro says the center will build on initiatives established under longtime and former OCE chief Richard Pazdur while using artificial intelligence (AI) and other approaches to streamline cancer-drug development and increase U.S. participation in clinical trials. Pazdur spent decades overseeing

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Group Calls for Policy Changes to Sustain Generic, Biosimilar Competition

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Exelixis NDA Review Extended for Colorectal Cancer Drug

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Pharming Group’s Joenja Gets Expanded Approval

FDA has granted Pharming Group expanded approval for Joenja (leniolisib) tablets for treating activated phosphoinositide 3-kinase delta syndrome (APDS) in children 4-11 years who weigh at least 27 kg. Joenja was first approved in 2023 for the same indication in patients 12 years and older at a dose

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Reduced Application Fees Not Sufficient Incentive: Column

FDA’s PDUFA 8 proposal to cut application fees by 50% for qualified drugs to conduct Phase I development in the U.S. is unlikely to achieve that intended result. That’s the opinion of Ovid Therapeutics executive chairman Jeremy Levin. Writing in a BioSpace opinion post, Levin says that

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Bill to Update FDA Drug Preclusion Rules

Rep. Diana Harshbarger (R-TN) has introduced the Dietary Supplement Innovation Act that she says would modernize FDA’s drug preclusion provision to establish regulatory certainty, ensure pharmaceutical innovation, and support consumer access to dietary supplements. In a statement (includes a link to the bill text and to a brief

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FDA Open to Alternative Approaches For Psychedelic Drug Trials

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

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FDA Partial Clinical Hold on Biohaven Epilepsy Drug

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

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Priority Review for Roche Enspryng sBLA

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

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AstraZeneca Reports Positive Data on COPD Biologic

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.

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Accelerated Rare Disease Cures Program Strategic Plan Out

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

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Breakthrough Therapy Designation for UCB’s Cimzia

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

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FDA Still Reviewing Rezolute Phase 3 Info

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

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Bayer Gets OK for Lung Cancer Drug

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

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FDA Eases Compounding for Neonatal Parenteral Nutrition 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

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FDA Acting Center Directors Made Permanent

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

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Krazati’s Accelerated Approval for Colorectal Cancer Withdrawn

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

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Intellia BLA Gets Priority Review for Hereditary Angioedema

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

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FDA Planning Pregnancy Exposure Registry Study

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)