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By press release submission | January 8, 2021
BAYER: U.S. FDA Approves Addition of Overall Survival and Other Secondary Endpoint Data to NUBEQA® (darolutamide) Prescribing Information
Phase III data showed treatment with NUBEQA resulted in a 31% reduction in risk of death, with a statistically significant…
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LOCATE BIO: CognitOss Granted FDA Breakthrough Device Designation
By press release submission | January 8, 2021
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NORTHSTAR MEDICAL RADIOISOTOPES: Announces FDA Approval for Enhanced U.S. Mo-99 Radioisotope Production Capacity
By press release submission | January 8, 2021
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KING & SPALDING: FDA and Life Sciences Team Adds Partner in Washington
By press release submission | January 8, 2021
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By press release submission | January 8, 2021
FUNCTIONAL NEUROMODULATION: Announces Breakthrough Device Designation from the U.S. FDA for Deep Brain Stimulation for Alzheimer’s Disease
Functional Neuromodulation announced today that it has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH)…
Business
ULTROMICS: Receives Fda Clearance for a First-of-kind Solution in Echocardiography to Help Clinicians Diagnose Disease
By press release submission | January 8, 2021
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ASTELLAS PHARMA INC.: FDA Accepts for Priority Review the New Drug Application for mirabegron for Oral Suspension and Supplemental New Drug Application for Myrbetriq® (mirabegron) Tablets in Pediatric Patients
By press release submission | January 8, 2021
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JUSTKN95MASKS.COM: Offers FDA-Approved KN95 Masks for Bulk and Wholesale Orders – Just in Time for President-Elect Biden’s Upcoming U.S. Face Mask Mandate
By press release submission | January 6, 2021
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By press release submission | January 6, 2021
FORGE BIOLOGICS: Announces FDA Clearance of Investigational New Drug Application for Phase 1/2 Clinical Trial (RESKUE) of FBX-101 Gene Therapy for Patients with Krabbe Disease
Forge Biologics has received IND, IBC, and IRB clearance for FBX-101, a gene therapy for patients with Krabbe disease, a…
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PROVENTION BIO: Announces U.S. FDA Filing of a Biologics License Application (BLA) and Priority Review for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-risk Individuals
By press release submission | January 6, 2021
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LEXAGENE: Starts FDA EUA Study for Point-of-Care COVID-19 Testing
By press release submission | January 3, 2021
Business
VISIONQUEST BIOMEDICAL INC.: Gains FDA 510(k) Clearance for the Image Quality Analyzer Software
By press release submission | January 2, 2021
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Trending
BAYER: U.S. FDA Approves Addition of Overall Survival and Other Secondary Endpoint Data to NUBEQA® (darolutamide) Prescribing Information
LOCATE BIO: CognitOss Granted FDA Breakthrough Device Designation
NORTHSTAR MEDICAL RADIOISOTOPES: Announces FDA Approval for Enhanced U.S. Mo-99 Radioisotope Production Capacity
KING & SPALDING: FDA and Life Sciences Team Adds Partner in Washington
FUNCTIONAL NEUROMODULATION: Announces Breakthrough Device Designation from the U.S. FDA for Deep Brain Stimulation for Alzheimer’s Disease
ULTROMICS: Receives Fda Clearance for a First-of-kind Solution in Echocardiography to Help Clinicians Diagnose Disease
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