FDA Archives - Page 30 of 220

1 minute read

Why Is Dementia Focused BioXcel Therapeutics Stock Trading Lower Today?

November 14, 3:01 PM

BioXcel Therapeutics Inc (NASDAQ: BTAI) announced alignment with the FDA's recommendation for a Phase 3 trial in the TRANQUILITY program of BXCL501 for acute treatment of agitation associated

BTAI

1 minute read

200% Gain In One Day – Why Is Heart Failure Focused BioCardia Stock Soaring Today?

By Vandana Singh

November 14, 12:05 PM

The FDA approved BioCardia Inc's (NASDAQ: BCDA) Phase 3 CardiAMP Heart Failure II study protocol of CardiAMP autologous cell therapy for

BCDA

2 minute read

NeuroSense Receives U.S. FDA Confirmation Of CMC Strategy For PrimeC In Preparation For Pivotal Phase 3 In ALS And Commercial Readiness

By Benzinga Newsdesk

November 13, 10:21 AM

Clinical efficacy top-line results of PARADIGM, a Phase 2b trial in ALS, expected in December 2023CAMBRIDGE, Mass., Nov. 13, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a company

NRSN

2 minute read

Zynex Submits FDA Application For Its Next Generation NMES Device

By Benzinga Newsdesk

November 13, 10:19 AM

Zynex, Inc. (NASDAQ:ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, today

ZYXI

1 minute read

FDA-Approved Synthetic THC Trials Show 21% Tic Reduction In Tourette Syndrome Patients

By Nicolas Jose Rodriguez

November 12, 10:09 PM

SciSparc Ltd. (NASDAQ: SPRC), a clinical-stage pharmaceutical company, reported a new Phase IIb trial of SCI-110, a proprietary THC-based medication for Tourette Syndrome (TS) treatment.

SPRC

2 minute read

Reported Nov 9, Neurocrine Biosciences Provides Development Pipeline Update; Failed To Demonstrate Meaningful Reduction In Seizure Frequency; Failed to Meet Its Primary Endpoint In Patients With Anhedonia In Major Depressive Disorder

By Benzinga Newsdesk

Today, 11:16 AM

Phase 2 Proof-of-Concept Study of NBI-921352 in Patients with Focal Onset Seizures Failed to Demonstrate Meaningful Reduction in Seizure FrequencyPhase 2 Proof-of-Concept Study of NBI-1065846 in Patients with Anhedonia

NBIX

1 minute read

FDA Approves World’s First Mosquito-Borne Chikungunya Vaccine

By Vandana Singh

Today, 8:37 AM

The FDA approved Valneva SE's (NASDAQ: VALN) Chikungunya single-dose vaccine in individuals

VALN

1 minute read

Back To Back FDA Approval For Takeda Within Two Days, Secures Green Signal For Rare Blood Disorder Therapy

By Vandana Singh

Today, 8:19 AM

The FDA approved Takeda Pharmaceutical Co Ltd's (NYSE:

TAK

2 minute read

FDA Grants Orphan Designation For Lipella’s LP-310 Drug Candidate For Oral Graft-Versus-Host Disease

By Benzinga Newsdesk

Today, 8:03 AM

Lipella Pharmaceuticals' LP-310 clinical stage asset is formulated for delivering active agents to the oral cavity for diseases of the mouth including oral lichen planus and oral graft-versus-host disease Lipella

LIPO

4 minute read

Madrigal Pharmaceuticals Presents New Data From The Phase 3 MAESTRO-NASH Trial Demonstrating Broad Treatment Effects Of Resmetirom On Noninvasive Measures Of Liver Health

By Benzinga Newsdesk

Today, 8:01 AM

Data to be featured in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting®Analyses from comprehensive set of noninvasive tests used in MAESTRO-NASH provide new

MDGL