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Boston Scientific Ranger Balloon OKd for PAD

[ Price : $8.95]

FDA approves Boston Scientifics Ranger Drug-Coated Balloon for treating patients with peripheral artery disease in the superficial...

Janssen sNDA for 6-month Schizophrenia Dosing

[ Price : $8.95]

Janssen Pharmaceutical files a supplemental NDA for paliperidone palmitate 6-month (PP6M) for treating adults diagnosed with schiz...

Salix Gets Orphan Status for Sickle Cell Drug

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FDA grants Salix Pharmaceuticals an orphan drug designation for rifaximin and its use in treating sickle cell disease.

FDA Withdraws 11 No-Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws approval of 11 ANDAs from multiple applicants after they notified the agency that the drug ...

Federal Court Hits Clinic Owner on Device Adulteration

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The Western Michigan District Court sentences Roger D. Beyer to 57 months in federal prison for his involvement in a conspiracy to...

Regeneron Interrupts Covid-19 Trial Enrollment

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Regeneron Pharmaceuticals says it will temporarily stop enrolling patients requiring high-flow oxygen or mechanical ventilation in...

Guide on Drug Standardized Study Date eSubmissions

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FDA posts a revised guidance on Providing Regulatory Submissions in Electronic Format Standardized Study Data.

Gene Therapy, Digital Health Boost in PDUFA Talks

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FDA user fee reauthorization meetings look to advance efforts associated with its Cell and Gene Therapy Program and Digital Health...

OPDP Director Tom Abrams Retires

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CDER Office of Prescription Drug Promotion director Tom Abrams retires after 27 years at FDA.

Medtronic Pays $8.1 Million to Settle Kickback Charges

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Medtronic agrees to pay $8.1 million to resolve allegations that it violated the False Claims Act by paying kickbacks to a physici...