Thursday, May 16, 2024

Thursday, May 16, 2024

Regulation

Proposed FDA vaping regulations are 'extensive, outdated,' AVA president says

By Amanda Smith-Teutsch | Nov 6, 2019

Regulation

FDA vaping regulations will hurt consumers, independents, CASAA says

By Amanda Smith-Teutsch | Oct 31, 2019

Regulation

FDA issued 13 warning letters in October

By FDA Reporter Submission | Oct 30, 2019

Latest News

BAYER: U.S. FDA Approves Addition of Overall Survival and Other Secondary Endpoint Data to NUBEQA® (darolutamide) Prescribing Information

FDA Approval

By Press release submission | Jan 8, 2021

Phase III data showed treatment with NUBEQA resulted in a 31% reduction in risk of death, with a statistically significant improvement in overall survival (OS) compared to placebo (HR=0.69, 95% CI 0.53-0.88; p=0.003), giving men with non-metastatic castration-resistant prostate cancer (nmCRPC) the opportunity to extend their lives

LOCATE BIO: CognitOss Granted FDA Breakthrough Device Designation

Regulation

By Press release submission | Jan 8, 2021

CognitOss is designed to treat osteomyelitis, a debilitating inflammatory bone infection

NORTHSTAR MEDICAL RADIOISOTOPES: Announces FDA Approval for Enhanced U.S. Mo-99 Radioisotope Production Capacity

FDA Approval

By Press release submission | Jan 8, 2021

Concentrated molybdenum-98 (cMo-98) enables up to four-fold increase of critical medical radioisotope Mo-99 production in U.S.

KING & SPALDING: FDA and Life Sciences Team Adds Partner in Washington

Reform

By Press release submission | Jan 8, 2021

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.

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