FDA Archives - Page 135 of 220

2 minute read

Qualigen Therapeutics Announces Pre-IND Feedback From U.S. FDA Regarding QN-302 For The Treatment Of G4-Targeted Advanced Solid Tumors

December 7, 10:11 AM

Qualigen Therapeutics, Inc. (("Qualigen" or "the Company, NASDAQ:QLGN), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug

QLGN

2 minute read

Moleculin Granted FDA Fast Track Designation Of WP1122 For The Treatment Of Glioblastoma Multiforme

By Benzinga Newsdesk

December 7, 9:47 AM

Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses,

MBRX

1 minute read

FDA
News

FDA Grants De Novo Classification To HLA Typing Test For Use As A Companion Diagnostic With A T Cell Receptor Therapy For Metastatic Or Unresectable Uveal Melanoma

By Benzinga Newsdesk

December 7, 9:06 AM

The SeCore CDx HLA Sequencing System is the first HLA typing test to receive marketing authorization by the FDA for use as a companion diagnostic

TMO

1 minute read

AVROBIO Announces Clinical Data For Gaucher Disease Gene Therapy; Says ‘Following positive feedback from FDA and MHRA, registrational, global Phase 2/3 clinical trial for GD3 planned for second half 2023’

By Bill Haddad

December 7, 8:33 AM

New compelling clinical data from first-ever Gaucher disease type 3 (GD3) patient and four Gaucher disease type 1 (GD1) patients dosed with investigational AVR-RD-02 Data from first pediatric GD3 patient, the more

AVRO

3 minute read

Reported Late Tuesday, MediciNova Announces Additional Results Regarding The Effects Of MN-001 On Serum Lipid Panel In Type 2 Diabetes And NAFLD Patients Presented At IDF 2022 Congress, The Annual Meeting Of The International Diabetes Federation

By Benzinga Newsdesk

December 7, 2:11 AM

ediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that MediciNova's Chief Medical

MNOV

3 minute read

INmune Bio Reports Combination Therapy With INB03™ Overcomes Resistance To Trastuzumab-Deruxtecan In MUC4 Expressing HER2+ Breast Cancer

By Benzinga Newsdesk

December 6, 5:01 PM

Neutralizing soluble TNF with INB03™ overcomes resistance to trastuzumab-deruxtecan in MUC4 expressing HER2+breast cancer. Combination therapy of INB03™ and trastuzumab-deruxtecan presented at the 45th

INMB

2 minute read

Cassava Sciences Announces Completion of Dosing In Open-Label Study Of Simufilam For Alzheimer’s Disease

By Benzinga Newsdesk

December 6, 10:16 AM

Outside Biostatisticians with Specific Expertise in Alzheimer's Disease Will Conduct an Independent Statistical Analysis on The Clinical Dataset. Clinical Dataset May Be Announced Approximately Year-End 2022,

SAVA

1 minute read

Gossamer Bio Announces Seralutinib Meets Primary Endpoint In Phase 2 TORREY Study In PAH

By Benzinga Newsdesk

December 6, 8:15 AM

- Primary Endpoint, Change in PVR at Week 24, Met with P-Value of 0.0310 - - Secondary Endpoint, Change in 6MWD, Numerically Favored Seralutinib - - Statistically Significant Improvements Observed in NT-proBNP and ECHO

GOSS

2 minute read

FDA
News

Mainz Biomed Earlier Announced IRB Approval and Initiation of US Pivotal FDA Clinical Study; Shares Up 18% Premarket

By Charles Gross

December 6, 6:37 AM

Mainz Biomed NV (NASDAQ: MYNZ) ("Mainz Biomed" or the "Company"), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it has received approval from an independent Institutional Review Board (IRB) for the protocol ReconAAsense, the Company's U.S.

MYNZ

3 minute read

MEI Pharma, Kyowa Kirin Earlier Announced Discontinuation Of Zandelisib Development Outside Of Japan Following Recent FDA Meeting

By Michael Horton

December 5, 6:40 PM

MEI Pharma, Inc. (NASDAQ:MEIP), a pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a Japan-based global specialty pharmaceutical company creating

MEIP