FDA Archives - Page 14 of 220

2 minute read

Chikungunya Vaccine Maker Valneva Secures Non Dilutive Funding To Develop/Expand Its Clinical Pipeline

February 5, 9:55 AM

Valneva sells FDA Priority Review Voucher for $103 million after FDA approval of Ixchiq, the world's first licensed chikungunya vaccine. Proceeds to boost R&D projects.

VALN

1 minute read

Why Obesity-Drug Maker NeuroBo Stock Is Trading Higher

By Erica Kollmann

February 1, 11:08 AM

NeuroBo announced that the FDA has cleared its IND application for DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). The company plans to initiate a Phase 1 clinical trial, for the treatment of obesity, in the first half of 2024.

NRBO

2 minute read

FDA Hosts Public Psychedelics Discussion, Discloses Major Growth On Number Of New Psychiatric Drugs Filings Post-2000

By Lara Goldstein

January 31, 8:05 PM

FDA and Reagan-Udall Foundation are hosting a virtual public meeting on psychedelic research titled Advancing Psychedelic Clinical Study Design, which aims to explore empirical approaches to address issues in drug development.

JNJ

1 minute read

Vanda Pharmaceuticals Announced Court Granted Vanda’s Motion For Summary Judgment On Its Claim Against The FDA

By Charles Gross

January 29, 8:08 PM

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the United States District Court for the District of Columbia granted Vanda's motion for summary judgment on its claim against the United States

VNDA

2 minute read

Pfizer’s COVID-19 Treatment Paxlovid Will No Longer Be Available For Emergency Use After This Date, FDA Revises Label

By Vandana Singh

January 29, 1:39 PM

FDA revises emergency use authorization for Pfizer's Paxlovid, impacting distribution and treatment of mild-to-moderate COVID-19. Transitions from March 8.

PFE

2 minute read

Dutch Health Tech Firm Philips Stops US Sales Of Respiratory Devices Under Finalized Consent Decree Over Device Recall

By Vandana Singh

January 29, 8:48 AM

Philips' Q4 earnings and FDA settlement insights. Learn about the consent decree, actions, future plans for Philips Respironics in the U.S. International services remain unaffected. Philips' 2024 forecasts and financial outlook.

PHG

2 minute read

Regeneron/Sanofi’s Largest Selling Drug Dupixent Scores FDA Approval For Infants With Esophagus Inflammation

By Vandana Singh

January 26, 9:53 AM

FDA approves Dupixent (dupilumab) by Regeneron/Sanofi for pediatric eosinophilic esophagitis treatment. Breakthrough treatment for young patients.

REGN

2 minute read

World’s Smallest Brain Stimulation Device For Movement Disorder: FDA Approved Abbott’s Liberta RC DBS system

By Vandana Singh

January 25, 4:19 PM

Abbott's Liberta RC DBS system, the world's smallest FDA-approved rechargeable deep brain stimulation device. With only 10 recharges a year, it's compatible with NeuroSphere Virtual Clinic, reducing the need for travel.

ABT

3 minute read

FDA
News

Abbott Received Approval From FDA To Launch The Liberta RC DBS System With Remote Programming Capabilities to Treat Movement Disorders

By Benzinga Newsdesk

January 25, 10:10 AM

Liberta RC™ deep brain stimulation (DBS) system, recently approved by the U.S. FDA, features NeuroSphere™ Virtual Clinic, which allows for remote programming of the systemSystem offers the longest time

ABT

1 minute read

Heron Therapeutics’ Non-Opioid, Post-Operative Pain Drug Approved For Use In Additional Orthopedic, Soft Tissue Procedures – FDA Gives Nod

By Vandana Singh

January 24, 12:47 PM

Zynrelef's expanded FDA approval for soft tissue and orthopedic surgeries, offering superior pain management with lower pain scores and opioid consumption.

HRTX