viernes, diciembre 6, 2019
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Etiqueta: FDA

Nuvectra Submits Chemical Composition and Biocompatibility Data to FDA for Virtis™ 

PLANO, Texas, Oct. 18, 2019 (GLOBE NEWSWIRE) -- Nuvectra Corporation (NASDAQ: NVTR), a neurostimulation medical device company, today announced it has submitted supplementary chemical composition and biocompatibility data to the U.S. Food and Drug Ad...

Achillion Receives Breakthrough Therapy Designation from FDA for Danicopan for Treatment...

– Danicopan Phase 2 PNH combination therapy topline data expected Q4 2019 –– Initiation of Phase 3 planned for early 2020 –

Capricor Therapeutics to Meet with FDA to Discuss CAP-1002 to Treat...

Company Exploring Potential for Accelerated Approval under RMAT Designation, an Expedited Program for Regenerative Therapies Company Exploring Potential for Accelerated Approval under RMAT Designation, an Expedited Program for Regenerative Therapies

Concept Medical Inc. Granted ‘Breakthrough Device Designation’ From the FDA for...

TAMPA, Fla.--(BUSINESS WIRE)--Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its...

Profound Medical Receives U.S. FDA 510(k) Clearance for TULSA-PRO®

U.S. Commercial Launch Expected in the 4th Quarter of 2019 U.S. Commercial Launch Expected in the 4th Quarter of 2019

PhaseBio Announces Receipt of Minutes of End-of-Phase 1 Meeting with the...

Clinical development plan and Accelerated Approval regulatory path confirmed

Daré Bioscience Receives QIDP Designation from the FDA for DARE-BV1 for...

DARE-BV1 Phase 3 registrational trial initiation expected in 4th quarter 2019 DARE-BV1 Phase 3 registrational trial initiation expected in 4th quarter 2019

Novavax Reaches Agreement with the FDA on Pivotal Phase 3 Trial...

Clinical trial expected to initiate in the fall of 2019 Clinical trial expected to initiate in the fall of 2019

B. Braun Interventional Systems Receives Breakthrough Device Designation Status from the...

BETHLEHEM, Pa., Aug. 01, 2019 (GLOBE NEWSWIRE) -- B. Braun Interventional Systems Inc. (BIS) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the SeQuent Please ReX drug-coated PTCA ball...

GENFIT: FDA and EMA Grant GENFIT’s Elafibranor Orphan Drug Designation for...

FDA and EMA Grant GENFIT’s Elafibranor Orphan Drug Designation for Primary Biliary Cholangitis (PBC)