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Regeneron Odronextamab BLA Rejected Again

[ Price : $8.95]

FDA issues Regeneron a second complete response letter on its BLA for odronextamab and its use in relapsed/refractory follicular l...

Allogene Modifies Lymphoma Trial After Patient Death

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Allogene Therapeutics modifies its ALPHA3 clinical trial for large B-cell lymphoma following the death of a patient attributed to ...

LENZ Therapeutics Get OK for Presbyopia Eye Drops

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FDA approves LENZ Therapeutics Vizz (aceclidine ophthalmic solution) 1.44% for treating presbyopia, a common age-related condition...

Illumina to Pay $9.8 Million in Cybersecurity Case

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Illumina agrees to pay $9.8 million to settle allegations that it violated the False Claims Act by selling genomic sequencing syst...

Draeger Recalls SafeStar 90 Plus Ventilator Filters

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Draeger recalls (Class 1) its SafeStar 90 Plus bidirectional breathing system filter after receiving reports of slow increase of C...

Novo Nordisk Hemophilia Drug Expanded Approval

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FDA approves Novo Nordisks Alhemo (concizumab-mtci) as a once-daily preventive treatment for bleeding episodes in patients 12 year...

FDA Makes ISTAND Pilot Permanent

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FDA says the Innovative Science and Technology Approaches for New Drugs pilot is transitioning into a permanent drug development t...

Trump Overruled Makary, RFK, to Fire Prasad: Sources

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Politico reports that despite strong support from FDA commissioner Martin Makary and HHS secretary Robert F. Kennedy, Jr., Preside...

Senate Amendment Seeks to Block Illicit Drug Imports

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U.S. Senators Ted Budd (R-NC) and Martin Heinrich (D-NM) introduce a bipartisan amendment to FDAs fiscal year 2026 spending bill t...

FDA Orders New Mandatory Opioid Labeling

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FDA orders new mandatory safety labeling changes for all opioid analgesics, a move aimed at curbing long-term misuse of the produc...