FDA Archives - Page 26 of 220

1 minute read

Why Is Chronic Disease Focused Biora Therapeutics Stock Trading Higher Today?

December 1, 11:01 AM

Biora Therapeutics Inc (NASDAQ: BIOR) announced that the FDA has cleared the company's Investigational New Drug (IND) application for BT-600, a drug/device combination for moderate to

BIOR

3 minute read

Cingulate Receives Guidance From FDA On Path Forward For Anxiety Asset CTx-2103 For The Treatment Of Anxiety Into Clinical Development

By Benzinga Newsdesk

December 1, 10:02 AM

Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation

CING

1 minute read

Why Is This Rare Disease-Focused Soligenix Stock Trading Over 200% Today?

By Vandana Singh

November 30, 1:07 PM

The FDA has cleared Soligenix Inc's (NASDAQ: SNGX) Investigational New Drug (IND) application for a Phase 2a clinical trial for SGX945 (dusquetide) for aphthous

SNGX

2 minute read

Scilex Holding Company Announces Successful FDA Audit Of Enhanced ZTlido Manufacturing Facility In Japan

By Benzinga Newsdesk

November 30, 10:00 AM

Enhanced 250kg manufacturing facility assures increased capacity to meet rapidly growing ZTlido® demand.Two new patents previously announced covering ZTlido® in the U.S. ensures proprietary protection through

SCLX

3 minute read

FDA Grants Lantern Pharma Orphan Drug Designation For Drug Candidate LP-284 In High-Grade B-cell Lymphomas

By Benzinga Newsdesk

November 30, 9:12 AM

The Orphan Drug Designation strengthens LP-284's clinical development path and can provide for additional market exclusivity and commercial protection.Lantern has initiated a first-in-human Phase 1 trial (NCT06132503)

LTRN

2 minute read

Edgewise Receives Orphan Drug And Rare Pediatric Disease Designations For Its Muscular Dystrophy Program From FDA

By Benzinga Newsdesk

November 30, 9:11 AM

Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a leading muscle disease biopharmaceutical company, today announced that the U.S. Food & Drug Administration (FDA) has granted EDG-5506 Orphan Drug Designation (ODD) for

EWTX

3 minute read

Desktop Health Announces First Patients Treated With FDA-Cleared CMFlex – An Off-The-Shelf 3D Printed Synthetic Bone Graft Product Pioneered By Dimension Inx On The 3D-Bioplotter

By Benzinga Newsdesk

November 29, 5:31 PM

Chicago-based Dimension Inx, a regenerative therapeutics company, has now had its innovative CMFlex material implanted in multiple patientsCMFlex is an off-the-shelf, customizable bone graft material indicated for

1 minute read

Why Is Sleep Disorder Device Provider Vivos Therapeutics Stock Trading Higher Today?

By Vandana Singh

November 29, 11:14 AM

Vivos Therapeutics Inc (NASDAQ: VVOS) received FDA 510(k) clearance for treating severe obstructive sleep apnea (OSA) in adults using the Vivos' removable CARE (Complete Airway Repositioning and/or Expansion)

VVOS

1 minute read

Why Is Philips Stock Trading Lower Today?

By Vandana Singh

November 29, 11:12 AM

Tuesday, the FDA issued a warning to patients and healthcare providers to carefully monitor

PHG

2 minute read

Dyadic Announces Top-Line Results From Its Successful Phase 1 Clinical Trial For A First-In-Human Filamentous Fungal-Based Vaccine Candidate; Primary Endpoint Met

By Benzinga Newsdesk

November 29, 9:32 AM

Primary endpoint metDemonstrated safety and reactogenicity of DYAI-100 recombinant proteinC1-cell produced antigen was both safe and well-toleratedNo Serious Adverse Events reportedFinal Clinical Study Report available

DYAI