FDA Archives - Page 149 of 220

3 minute read

Nkarta Presents Data Supporting Engineered NK Cell Based Combination Therapies And Next Generation Commercial-Scale Manufacturing Platform At SITC 37th Annual Meeting

November 7, 9:54 AM

Improved Anti-Tumor Activity Demonstrated by the Combination of NKX019 and a CD20-directed Monoclonal Antibody in Preclinical Models Pulsed Stimulation of NK Cells Derived from Peripheral Blood of Healthy Donors

NKTX

3 minute read

enVVeno Medical Successfully Passes Preliminary FDA Safety Review For The VenoValve U.S. Pivotal Study

By Benzinga Newsdesk

November 7, 9:46 AM

The Company submitted safety data for the first 20 patients enrolled in the ongoing SAVVE U.S. pivotal study for the VenoValve Following the initial safety data review by the FDA, the SAVVE study is cleared to continue

NVNO

3 minute read

NextCure Presents Initial Data From Clinical Trial Of NC762 And A Trial In Progress Poster For NC410 Combo At The 2022 Society For Immunotherapy Of Cancer Annual Meeting

By Benzinga Newsdesk

November 7, 9:12 AM

NextCure, Inc. (NASDAQ:NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today

NXTC

4 minute read

Fate Therapeutics Announces Exercise By ONO Pharmaceutical Of Option To HER2-Targeted CAR T-Cell Product Candidate For Solid Tumors

By Benzinga Newsdesk

November 7, 9:10 AM

Multiplexed-engineered, iPSC-derived CAR T-cell Product Candidate Demonstrated Broad, Potent and Specific CAR Activity Across Multiple Preclinical Solid Tumor Models Fate and ONO to Jointly Develop and

FATE

2 minute read

Anavex Life Sciences Announced Orphan Drug Designation to Anavex2-73 (Blarcamesine) for the Treatment of Fragile X Syndrome

By Charles Gross

November 7, 7:57 AM

Anavex Life Sciences Corp.

AVXL

1 minute read

Reported Late Thursday, AVITA Medical Announces FDA Breakthrough Device Designations For The RECELL System

By Benzinga Newsdesk

November 4, 12:53 AM

AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH)))), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, announced

RCEL

1 minute read

FDA
News

Apellis Announces Plans To Submit 24-Month Phase 3 Data To FDA For Pegcetacoplan NDA For Geographic Atrophy

By Benzinga Newsdesk

November 3, 5:20 PM

Inclusion of the 24-month data has the potential to strengthen the product profile at launch, with minimal impact to launch timing Submission will be a Major Amendment to the New Drug Application (NDA), extending

APLS

5 minute read

Chinook Therapeutics Presents Updated Data From Atrasentan Phase 2 AFFINITY IgA Nephropathy Patient Cohort, Preclinical Atrasentan Research And Ongoing Clinical Trials At The American Society Of Nephrology Kidney Week 2022

By Benzinga Newsdesk

November 3, 10:07 AM

Atrasentan was well-tolerated with no treatment-related serious adverse events (SAEs) Atrasentan demonstrated mean proteinuria reductions of 38.1% proteinuria at six weeks of treatment, 48.3% at

KDNY

4 minute read

Kezar Life Sciences Presents Complete Results From The MISSION Phase 2 Trial Evaluating Zetomipzomib In Lupus Nephritis At ASN’s Kidney Week 2022 Annual Meeting

By Benzinga Newsdesk

November 3, 10:01 AM

Zetomipzomib added to stable background therapy reduced proteinuria by 50% or greater (ORR) in 11 of 17 patients (64.7%) reaching end of treatment at Week 25. This benefit occurred with a 53% mean

KZR

1 minute read

Schrödinger To Present New Preclinical Data From Its CDC7 Inhibitor Program At American Society Of Hematology 2022 Annual Meeting

By Benzinga Newsdesk

November 3, 9:51 AM

Schrödinger, Inc. (NASDAQ:SDGR), whose physics-based computational platform is transforming the way therapeutics and materials are discovered, today announced that new preclinical data on its CDC7 inhibitor,

SDGR