FDA Reporter

King & Spalding announced that Marisa Maleck rejoins the firm as a partner in the FDA and Life Sciences team, which is part of the Government Matters practice.

FUNCTIONAL NEUROMODULATION: Announces Breakthrough Device Designation from the U.S. FDA for Deep Brain Stimulation for Alzheimer's Disease

Regulation

By Press release submission | Jan 8, 2021

Functional Neuromodulation announced today that it has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for the Vercise™ Deep Brain Stimulation (DBS) Systems, developed and manufactured by Boston Scientific Corporation, in the treatment of patients 65 years and older with mild probable Alzheimer's disease.

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

Patients

By Press release submission | Jan 8, 2021

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the U.S. Food and Drug Administration (FDA) accepted priority review for its New Drug Application (NDA) for mirabegron for oral suspension and its supplemental New Drug Application (sNDA) for Myrbetriq® (mirabegron) tablets for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older.

ULTROMICS: Receives Fda Clearance for a First-of-kind Solution in Echocardiography to Help Clinicians Diagnose Disease

Regulation

By Press release submission | Jan 8, 2021

EchoGo Pro is an AI service for automated identification of coronary artery disease

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

FDA Approval

By Press release submission | Jan 6, 2021

JustKN95Masks.com (https://justkn95masks.com/) announced that its warehouse was fully stocked with over 250,000 FDA-registered, fully certified KN95 respirators to help meet the growing demand for face masks in the United States.

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

Patients

By Press release submission | Jan 6, 2021

Forge Biologics has received IND, IBC, and IRB clearance for FBX-101, a gene therapy for patients with Krabbe disease, a rare and fatal genetic disorde

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

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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

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

ULTROMICS: Receives Fda Clearance for a First-of-kind Solution in Echocardiography to Help Clinicians Diagnose Disease

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

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

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