FDA Archives - Page 110 of 220

5 minute read

Nexcella, A Subsidiary Of Immix Biopharma, Presents 42-Patient Interim Data, With 90% Overall Response Rate In Relapsed Or Refractory Multiple Myeloma At NXC-201 Therapeutic Dose From Its Phase 1 Expansion Trial At The 5th European Car T-Cell Meeting

February 9, 9:13 AM

The poster presents data for 42 patients with relapsed or refractory multiple myeloma who were treated with NXC-201 (formerly HBI0101), of which 29 received the therapeutic dose of 800 million CAR+T cells as of the

IMMX

1 minute read

FDA
News

Gilead Highlights Kite’s Tecartus CAR T-Cell Therapy Data In 3-Year Follow-Up Of Pivotal ZUMA-3 Trial

By Benzinga Newsdesk

February 9, 8:33 AM

-- In Three-Year Follow-up in Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia, Tecartus Shows High Rates of Durable Response (CR+CRi 71%) and a Median Overall Survival of 26 Months --

GILD

1 minute read

FDA
News

FDA Granted Mesoblast Regenerative Medicine Advanced Therapy Designation granted For Rexlemestrocel-L In Chronic Low Back Pain

By Charles Gross

February 8, 6:51 PM

Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today announced that the United States Food and Drug Administration's (FDA) Office of Tissues and Advanced Therapies (OTAT) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for rexlemestrocel-L in the treatment of chronic low back pain (CLBP) associated with disc degeneration, in combination with hyaluronic acid (HA) as delivery agent

MESO

1 minute read

First Wave Bio New Clinical Trial Study ‘Pilot Study To Assess Safety And Efficacy Of An Enteric Microgranule Formulation Of Adrulipase In Patients With Exocrine Pancreatic Insufficiency Due To Cystic Fibrosis.’

By Happy Mohamed

February 8, 1:21 PM

https://clinicaltrials.gov/ct2/show/NCT05719311 Brief Summary:

FWBI

2 minute read

Hoth Therapeutics Announces Increased Results Of Its Alzheimer’s Therapeutic HT-ALZ; Shows Cognitive Improvements In Alzheimer’s Disease Mouse Model And Results Show Reduced Anxiety And Improved Performance

By Happy Mohamed

February 8, 9:44 AM

HT-ALZ Therapeutic Shows Cognitive Improvements in Alzheimer's Disease Mouse Model and Results Show Reduced Anxiety and Improved Performance NEW YORK, Feb. 8, 2023 /PRNewswire/ -- Hoth Therapeutics, Inc.

HOTH

1 minute read

PharmaTher Seeks Regulatory Approval Of New Ketamine Delivery System For Anesthesia And Sedation

By Lara Goldstein

February 7, 4:36 PM

Specialty ketamine company PharmaTher Holdings Ltd.

PHRRF

2 minute read

Lixte Biotechnology Holdings Reports That Its Lead Clinical Compound, LB-100, Can Kill Cancer Cells Through Hyper-Stimulation Of Cell Proliferation Signals In Pre-Clinical Models; Shares Halted On Circuit Breaker To The Upside

By Happy Mohamed

February 7, 1:19 PM

--THE STUDY ESTABLISHES A NOVEL CONCEPT OF "TUMOR SUPPRESSIVE DRUG RESISTANCE" --THE COMBINATION OF LB-100 WITH INHIBITORS OF CELLULAR STRESS RESPONSE MODULATORS WAS HIGHLY EFFECTIVE IN

LIXT

1 minute read

FDA
News

AC Immune Awarded New Grants From MJFF, Target ALS Supporting Programs Targeting TDP-43

By Benzinga Newsdesk

February 7, 8:05 AM

The Michael J. Fox Foundation grant supports the development of AC Immune's first-in-class TDP-43 PET tracer program Target ALS Foundation grant supports collaboration between AC Immune and world-class

ACIU

1 minute read

FDA
News

Teva Granted FDA Tentative Approval For Type 5 – New Formulation or New Manufacturer Of PACLITAXEL

By Charles Gross

February 7, 6:14 AM

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216338

TEVA

3 minute read

T2 Biosystems Advances To The Phase 2 In HHS And The Steven And Alexandra Cohen Foundation’s LymeX Diagnostics Prize

By Happy Mohamed

February 6, 5:22 PM

T2 Biosystems, Inc. (NASDAQ:TTOO) a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today that it has advanced to the Phase 2 accelerator in the U.S. Department of

TTOO