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FDA Introduces Overdose Prevention Framework

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FDA commissioner Robert Califf says the agency has launched a drug overdose prevention framework with four overarching priorities.

FDA Lifts Hold on Curis Leukemia Study

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FDA lifts a partial clinical hold on Curis TakeAim Leukemia study that is intended to evaluate emavusertib in a monotherapy phase ...

Hamilton Medical Ventilator Recalled

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Hamilton Medical recalls its Hamilton-C6 Intensive Care Ventilator after customer complaints were received about a hardware issue ...

Outlook Resubmits ONS-5010 BLA

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Outlook Therapeutics resubmits to FDA a BLA for its ONS-5010 to treat wet age-related macular degeneration.

Erytech Scraps Plans for Leukemia BLA

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Erytech Pharma says it is no longer planning to submit a BLA for Graspa in hypersensitive acute lymphoblastic leukemia following F...

Farxiga Phase 3 Data Show Mortality Benefit

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New Phase 3 data on AstraZeneca's Farxiga (dapagliflozin) demonstrate a mortality benefit compared to placebo in patients with hea...

Intera Oncology Recalls Hepatic Artery Pump

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Intera Oncology recalls its Intera 3000 Hepatic Artery Infusion Pump due to complaints the device was delivering medications faste...

2 Draft Guides on Drug Analytical Procedures

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Federal Register notice: FDA posts two draft guidances entitled Q2(R2) Validation of Analytical Procedures and Q14 Analytical Proc...

bluebird bio Wins Priority Voucher

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Federal Register notice: FDA issues bluebird bio a priority review voucher for obtaining approval of Zynteglo (betibeglogene autot...

BMS, Janssen Moving Stroke Drug to Phase 3

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After reporting Phase 2 data, Bristol Myers Squibb and Janssen Pharmaceuticals say they are planning to begin a Phase 3 trial of t...