FDA Archives - Page 132 of 220

1 minute read

Annogen Announces Research Project With Pfizer To Test Non-Coding Genetic Sequences

December 13, 9:55 AM

Annogen will functionally annotate tens of thousands of disease-related non-coding sequence variants with the goal of aiding drug discovery Annogen, the Amsterdam based biotech company behind the SuRE™ technology

PFE

1 minute read

Immix Biopharma Announces Patient Dosing In Ongoing Phase 1b/2a IMX-110 Monotherapy Clinical Trial

By Benzinga Newsdesk

December 13, 9:03 AM

In December 2022, the 15th patient was dosed with IMX-110 IMX-110 clinical trial data expected to be released on a rolling basis beginning in Q1 2023; once dosing begins, patients undergo CT scans every

IMMX

1 minute read

Aldeyra Therapeutics’ Investigational RASP Modulator ADX-629 Improved Signs Of Intoxication In Alcohol Challenge Phase 2 Clinical Trial

By Benzinga Newsdesk

December 13, 9:01 AM

Relative to Placebo, ADX-629 Reduced Dermal Flushing (P=0.0007), Increased Romberg Test Balance Time (P=0.02), and Lowered Levels of Acetaldehyde (P=0.03) Following Exposure to Alcohol Aldeyra Plans to Support

ALDX

1 minute read

Cellectis Announces Preliminary Clinical Data For UCART22 In ALL And UCART123 In AML

By Benzinga Newsdesk

December 13, 8:37 AM

UCART22: anti-tumor activity observed in 60% (n=3) of patients at DL3 using FCA lymphodepletion UCART123: 25% (n=2) of patients at DL2 in the FCA arm achieved meaningful response; one patient

CLLS

2 minute read

Indaptus Therapeutics Announces Initiation Of First-In-Human, Open Label, Dose Escalation And Expansion Multicenter Phase 1 Clinical Trial Of Decoy20 In Patients With Advanced Solid Tumors

By Benzinga Newsdesk

December 13, 8:32 AM

Indaptus Therapeutics, Inc. (NASDAQ:INDP, ", Indaptus", or ", the Company", )))), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announces

INDP

1 minute read

FDA
News

Cytokinetics Announced Stock Trading Halted Today for FDA Panel to Review NDA for Omecamtiv Mecarbil

By Charles Gross

December 13, 8:03 AM

Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Nasdaq has halted the trading of the Company's common stock. The U.S.

CYTK

1 minute read

Another Competitor For Amgen As FDA Approves Mirati Therapeutics’ KRAS Inhibitor For Lung Cancer Setting

By Vandana Singh

December 13, 7:45 AM

The FDA granted accelerated approval to Mirati Therapeutics Inc (NASDAQ:MRTX) Krazati (adagrasib), a targeted treatment option for adult patients with KRASG12C-mutated locally…

MRTX

1 minute read

FDA
News

Teva Received FDA Approval for Tasimelteon

By Charles Gross

December 13, 5:44 AM

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211601

TEVA

4 minute read

Galapagos And CellPoint Presented Initial Data At ASH 2022 For GLPG5101, A CD19 CAR-T Candidate Manufactured At Point-Of-Care

By Benzinga Newsdesk

December 13, 3:04 AM

6 out of 7 eligible patients with relapsed/refractory Non-Hodgkin Lymphoma (rrNHL) responded to treatment (ORR of 86%) and all responding patients achieved complete response (CR) No grade 3 or higher cytokine

GLPG

3 minute read

Reported Late Monday, Agilent Resolution ctDx FIRST Receives FDA Approval As A Liquid Biopsy Companion Diagnostic Test For Advanced Non-small Cell Lung Cancer

By Benzinga Newsdesk

December 13, 1:37 AM

Agilent Technologies Inc. (NYSE:A) announced today that the U.S. Food and Drug Administration (FDA) has approved Agilent Resolution ctDx FIRST as a companion diagnostic (CDx) to identify advanced non-small cell lung