FDA - Spark Newswire

1 minute read

Intelligent Bio Solutions Has Filed A 513(G) Submission With The FDA For Its Intelligent Fingerprinting Drug Screening Cartridge

Today, 6:24 PM

The submission will allow Intelligent Bio Solutions to determine the most suitable FDA regulatory pathway as part of the Company's strategy for expansion into the U.S. market. The Intelligent Fingerprinting

INBS

3 minute read

Pharming Provides Update On European Medicines Agency Regulatory Review Of Leniolisib For APDS In Europe; Decided To Shift Its Assessment Of The Marketing Authorisation Application For Leniolisib To A Standard Review Timetable

By Happy Mohamed

Today, 6:24 PM

EMA Marketing Authorisation Application for leniolisib changed to standard review timetable LEIDEN, Netherlands, Feb. 16, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the

PHAR

5 minute read

Emergent BioSolutions Reports FDA Advisory Committees’ Unanimous Vote In Favor Of NARCAN Nasal Spray, A Nonprescription Opioid Overdose Reversal Agent For Over-The-Counter Use

By Happy Mohamed

Today, 6:24 PM

If approved by the FDA, NARCAN Nasal Spray will be the first 4 mg naloxone nasal spray switched from prescription status to over-the-counter use GAITHERSBURG, Md., Feb. 15, 2023 (GLOBE NEWSWIRE) --

EBS

2 minute read

Charles River And Purespring Therapeutics Announce Gene Therapy Manufacturing Collaboration

By Happy Mohamed

Today, 6:24 PM

Plasmid CDMO alliance supports first gene therapy platform targeting kidney diseases Charles River Laboratories International, Inc. (NYSE:CRL) and Purespring Therapeutics, a pioneering gene therapy company

CRL

4 minute read

Axcella Announces FDA IND Clearance Supporting Regulatory Path To Registration Of AXA1125 For Long COVID Fatigue

By Happy Mohamed

Today, 6:24 PM

Phase 2b/3 study may proceed under U.S. Investigational New Drug application Study design now accepted by U.S. and U.K. regulatory authorities Axcella to present at Long COVID forum co-sponsored by BIO and Solve

AXLA

2 minute read

Medical Cannabis For Autism: Zelira Receives $8.6M For FDA Clinical Trials For Treatment

By Joana Scopel

Today, 6:24 PM

Zelira Therapeutics Ltd (ASX: ZLD) (OTCQB: ZLDAF), a developer of cannabinoid-based medicines, will conduct FDA Phase 2 and Phase 3 clinical trials for its HOPE-1 treatment of Autism Spectrum Disorder (ASD).

ZLDAF

1 minute read

FDA
News

DermTech Products Added To Department Of Veterans Affairs National Acquisition Ceter Catalog

By Benzinga Newsdesk

Today, 6:24 PM

https://www.vendorportal.ecms.va.gov/NAC/Search/Details/36F79723D0013

DMTK

1 minute read

World Health Organization Tweets ‘The IHR Emergency Committee For Monkey Pox Multi-Country Outbreak Advised That MPOX Remains A Public Health Emergency Of International Concern And Tedros Adhanom Ghebreyesus Accepted Their Advice’

By Happy Mohamed

Today, 6:24 PM

https://twitter.com/WHO/status/1625906369084948482

GOVX

4 minute read

Collaboration With Kiora Pharmaceuticals And The Royal Adelaide Hospital, Leading Australian CRO, Accelagen Clinical Trial Underway To Improve Vision In Individuals With Advanced Retinitis Pigmentosa

By Happy Mohamed

Today, 6:24 PM

Putting Australian clinical research on the map globally, comes the ground-breaking first-in-human clinical trial for KIO-301. MELBOURNE, Australia, Feb. 14, 2023 /PRNewswire/ -- In collaboration with US-based

KPRX