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Regulatory Intelligence & Drug Approvals4 weeks agoLilly’s BTK drug Jaypirca joins first-line options in US
Lilly's noncovalent BTK inhibitor Jaypirca has been cleared by the FDA for its first frontline indication, but will it be reserved for later-line use?
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Regulatory Intelligence & Drug Approvals4 weeks agoSTAT+: Lilly’s Jaypirca approved as first-line CLL therapy
Eli Lilly’s Jaypirca has won FDA approval for previously untreated chronic lymphocytic leukemia and small lymphocytic lymphoma.
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Regulatory Intelligence & Drug Approvals4 weeks agoAdvisory Committees Give FDA Critical Advice and the Public a Voice
At the FDA, we rely on our many advisory committees to help us make sound decisions based on the best science available. Advisory committees give our...
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Regulatory Intelligence & Drug Approvals4 weeks agoShionogi’s diversification continues with $2bn IntraBio buy
Shionogi has reached a $2bn agreement to buy Anglo-US biotech IntraBio and its recently approved Aqneursa therapy for two rare genetic disorders.
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Regulatory Intelligence & Drug Approvals4 weeks agoFDA approves expanded indication for Lilly’s Jaypirca
Jaypirca is a non-covalent Bruton tyrosine kinase (BTK) inhibitor and is administered orally as 50mg or 100mg tablets to achieve a daily 200mg dose. The regulatory...
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Regulatory Intelligence & Drug Approvals4 weeks agoWithdrawn | Cancer Accelerated Approvals
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.
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Regulatory Intelligence & Drug Approvals4 weeks agoSTAT+: Are stem cells the next peptides? These advocates think RFK Jr. could make it happen
Peptides gained legitimacy at the FDA after being embraced by MAHA. Advocates hope stem cell treatments will follow the same path.
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Regulatory Intelligence & Drug Approvals4 weeks agoOpinion: FDA must ensure American patients can access new and experimental drugs
The FDA has taken important steps through Operation TrialBlazer and stronger scrutiny of foreign clinical data, but more must be done to make the United States...
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Regulatory Intelligence & Drug Approvals4 weeks agoInfusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets
BD Alaris Pump Infusion Sets are being removed and discontinued; Alaris Pump Module model 8100 has updated performance data
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Regulatory Intelligence & Drug Approvals4 weeks agoLilly’s Jaypirca (pirtobrutinib), the First-and-Only Approved Non-Covalent BTK Inhibitor, Receives Expanded Indication from U.S. FDA for Certain Patients with Previously Untreated CLL/SLL
INDIANAPOLIS, Oct. 2, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved an additional...
Opentrons Raises $40M in Series E to Expand Its Robotics, Software, Data Infrastructure
100 Million-Cell AI-Ready Dataset with Single-Cell and Proteomic Data Created by Parse and Nomic
No Nonsense: David Liu Lauds Progress in Disease-Agnostic Gene Editing at ESGCT
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
