FDA Archives - Page 22 of 220

4 minute read

Masimo Receives FDA Clearance For Stork Baby Monitoring System

December 18, 2:02 PM

Stork Provides Continuous Monitoring of Oxygen Saturation, Pulse Rate, and Skin Temperature, with Alarms, for Sick and Healthy Babies at HomeMasimo (NASDAQ:MASI), a global leader in innovative monitoring technologies

MASI

4 minute read

Psyched: Biden’s Big Decision On Psychedelics Therapy; LSD Anxiety Results; Matthew Perry Autopsy And More

By Lara Goldstein

December 18, 1:21 PM

Biden To Decide On Psychedelic Therapy Bill

ATAI

1 minute read

Why Is Diagnostics Products Focused Biomerica Stock Trading Higher Today?

By Vandana Singh

December 18, 10:24 AM

Biomerica Inc (NASDAQ: BMRA) has received FDA 510(k) clearance for its Hp Detect Stool Antigen ELISA test, designed to detect the presence of the

BMRA

1 minute read

FDA
News

Sysco And iFoodDS To Explore Flexible Network Solutions For FSMA 204 Food Traceability Rule Compliance

By Happy Mohamed

December 18, 10:05 AM

Sysco Corporation (NYSE:SYY), and iFoodDS announced a proof-of-concept project to explore solutions that enable Sysco and its diverse supplier base to capture, store, and share data required by the U.S. Food and Drug

SYY

2 minute read

Neuronetics Receives FDA 510(k) Clearance For NeuroSite Coil Placement Accessory That Simplifies Measurement And Coil Positioning During Neurostar Transcranial Magnetic Stimulation Treatments

By Benzinga Newsdesk

December 18, 9:50 AM

Neuronetics, Inc. (NASDAQ:STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced the

STIM

1 minute read

Mirum Pharmaceuticals Announces Data From EMBARK Phase 2b Study for Biliary Atresia; Study Did Not Meet Primary Or Secondary Endpoints

By Benzinga Newsdesk

December 18, 9:33 AM

- Study did not meet primary or secondary endpoints.- LIVMARLI was generally well-tolerated, with no new safety findings.Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM), today announced top-line results of the Phase 2 EMBARK

MIRM

2 minute read

Elutia Submits CanGarooRM Antibiotic-Eluting Biomatrix For FDA Clearance; 510(k) Filing Follows FDA Feedback From Successful Pre-Submission Meeting

By Benzinga Newsdesk

December 18, 9:02 AM

Elutia Inc. (NASDAQ:ELUT) today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its next-generation drug-eluting biomatrix product, CanGarooRM®. Tailored

ELUT

1 minute read

FDA Approves Arcutis Biotherapeutics’ Lead Drug For Scaly Skin Disorder

By Vandana Singh

December 18, 8:03 AM

The FDA approved Arcutis Biotherapeutics Inc's (NASDAQ: ARQT) Zoryve (roflumilast) topical foam, 0.3% for seborrheic dermatitis in individuals

ARQT

2 minute read

Arcutis Biotherapeutics Says STRATUM Study Met Its Primary Endpoint, With Nearly 80% Of ZORYVE Foam Treated Individuals Reaching Investigator Global Assessment; Also Demonstrated Improvement On All Secondary Endpoints, Including Itch, Scaling And Eryth…

By Benzinga Newsdesk

December 16, 7:57 PM

ZORYVE Foam Clinical DataThe approval is supported by positive results from Arcutis' Phase 2 and pivotal Phase 3 trials in seborrheic dermatitis. The STudy of Roflumilast

ARQT

5 minute read

FDA Approves Arcutis’ ZORYVE Topical Foam, 0.3% For The Treatment Of Seborrheic Dermatitis In Individuals Aged 9 Years And Older

By Happy Mohamed

December 16, 7:41 PM

ZORYVE foam represents a highly effective, safe, well-tolerated, once-daily steroid-free foam for use on all affected areas of the body, including hair-bearing areas, with no limitations on duration of use ZORYVE foam

ARQT