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Regulatory Intelligence & Drug Approvals2 weeks agoNewly Added Guidance Documents
Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.
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Regulatory Intelligence & Drug Approvals2 weeks agoOncology (Cancer)/Hematologic Malignancies Approval Notifications
FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing...
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Regulatory Intelligence & Drug Approvals2 weeks agoFDA grants accelerated approval to camizestrant with a CDK4/6 inhibitor for ESR1-Mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer
On September 4, 2026, the Food and Drug Administration granted accelerated approval to camizestrant (Etcamah, AstraZeneca), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor...
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Regulatory Intelligence & Drug Approvals2 weeks agoFDA Grants Accelerated Approval to a New Breast Cancer Treatment
The U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and...
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Regulatory Intelligence & Drug Approvals2 weeks agoTrailing rivals, AbbVie scores win with dual-acting myeloma drug
The drugmaker is leaning on a better side effect profile compared to drugs from J&J, Pfizer and Regeneron as it pushes etentamig toward FDA submission.
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Regulatory Intelligence & Drug Approvals2 weeks agoSTAT+: FDA takes another look at botanical drugs
The biggest barrier for a top schzophrenia treatment, Ionis' first approval for Alexander disease, and more biotech news
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Regulatory Intelligence & Drug Approvals2 weeks agoDrugs@FDA Data Files
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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Regulatory Intelligence & Drug Approvals2 weeks agoNewest glue degrader nabs multiple myeloma approval
Nature Reviews Drug Discovery, Published online: 04 September 2026; doi:10.1038/d41573-026-00147-wNewest glue degrader nabs multiple myeloma approval
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Regulatory Intelligence & Drug Approvals2 weeks agoIonis claims first approval for Alexander disease therapy
Ionis' Zanvastro has been approved by the FDA for Alexander disease, becoming the first disease-modifying therapy for the devastating rare disease.
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Regulatory Intelligence & Drug Approvals2 weeks agoFDA approves Ionis’ antisense drug as first targeted therapy for Alexander disease
Zanvastro, an antisense oligonucleotide therapy, represents the first independent neurology launch for Ionis Pharmaceuticals, which intends to leverage the foothold for more approvals in rare neurodegenerative...
FDA warning letter accuses Bausch & Lomb of lacking commitment to remediation
Deep dive: Psychedelics back on FDA’s doorstep
‘Patients are not a renewable resource’: Rethinking rare disease R&D
Scientists turn pig semen extract into eye drops that kill cancer in mice
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
