FDA Archives - Page 74 of 220

4 minute read

NeuroSense Therapeutics Reports Preliminary Results In Parkinson’s Biomarker Study; Shares Move Higher

May 2, 8:32 AM

Statistically significant decreased levels of novel biomarker AGO2 (p= 0.002) observed in newly diagnosed people living with Parkinson's disease (PD) compared to healthy individualsNeuroSense's combination platform has

NRSN

3 minute read

EXCLUSIVE: AMA Moves Toward Psychedelic Therapy Reimbursement, ‘Filing A Gap’ In Regulations

By Lara Goldstein

May 2, 7:00 AM

The American Medical Association (AMA) is expected to issue the first code for psychedelic therapy reimbursement, following Tuesday's approval of a joint application submitted by MAPS PBC and COMPASS Pathways (NASDAQ: CMPS).

CMPS

4 minute read

Travere Therapeutics Announces Topline Results From Two-Year Primary Efficacy Endpoint In Pivotal Phase 3 DUPLEX Study Of Sparsentan In Focal Segmental Glomerulosclerosis; The Duplex Study Did Not Achieve The Primary Efficacy Endpoint Over 108 Weeks

By Happy Mohamed

May 1, 4:29 PM

The DUPLEX Study did not achieve the primary efficacy eGFR slope endpoint over 108 weeks of treatment Secondary and topline exploratory endpoints trended favorably for sparsentan Treatment with sparsentan resulted in a

TVTX

1 minute read

Why Avadel Pharma Shares Are Gaining Today

By Vandana Singh

May 1, 2:34 PM

Avadel Pharmaceuticals plc’s (NASDAQ:AVDL) shares are up Monday after the FDA granted final approval to Lumryz, an extended-release formulation of sodium…

AVDL

1 minute read

FDA Approves Medtronic’s Next Generation Micra Leadless Pacing Systems

By Vandana Singh

May 1, 2:12 PM

The FDA has approved Medtronic plc's (NYSE: MDT) Micra AV2 and Micra VR2, the next generation of its

MDT

4 minute read

Avadel Pharmaceuticals Announces Final FDA Approval Of LUMRYZ For Extended-Release Oral Suspension As The First And Only Once-At-Bedtime Oxybate For Cataplexy Or Excessive Daytime Sleepiness In Adults With Narcolepsy

By Benzinga Newsdesk

May 1, 1:21 PM

- Granted Orphan Drug Exclusivity through May 1, 2030 --Advanced commercial preparations on track; LUMRYZ product availability expected in early June -- Final approval supported by robust efficacy and safety data from

AVDL

1 minute read

FDA Rejects Ascendis Pharma’s TransCon PTH For Hypoparathyroidism

By Vandana Singh

May 1, 1:02 PM

The FDA issued a complete response letter (CRL) for Ascendis Pharma A/S's

ASND

2 minute read

Medtronic Receives FDA Approval For Its Next Generation Micra Leadless Pacing Systems

By Benzinga Newsdesk

May 1, 9:33 AM

New pacemakers offer 40% more battery life,1 extend Medtronic legacy of pacing leadershipDUBLIN, May 1, 2023 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it has

MDT

1 minute read

Why Nano-X Imaging Stock Is Surging Monday

By Adam Eckert

May 1, 9:07 AM

Shares of medical imaging technology company Nano-X Imaging Ltd (NASDAQ: NNOX) are trading higher Monday after the company said it received 510(k) clearance from the FDA to market the Nanox.ARC as a

NNOX

1 minute read

Evoke Pharma Announces New GIMOTI Patent Listed In FDA Orange Book

By Benzinga Newsdesk

May 1, 8:42 AM

Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray,

EVOK