FDA Archives - Page 153 of 220

2 minute read

G1 Therapeutics Announces Investigator Initiated Study Of Trilaciclib And Lurbinectedin In Patients With Extensive Stage Small Cell Lung Cancer

October 26, 9:27 AM

G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that it is supporting a Phase 2 investigator initiated study (ISS) of trilaciclib and lurbinectedin in patients

GTHX

6 minute read

New Analysis Of UPLIZNA Phase 3 Trial Data Demonstrates Importance Of Reducing Plasmablasts To Help Prevent Neuromyelitis Optica Spectrum Disorder Attacks

By Benzinga Newsdesk

October 26, 9:01 AM

-- Separate analysis also being presented at ECTRIMS 2022 reinforces the efficacy of UPLIZNA in patients with genetic variations --

HZNP

2 minute read

Jaguar Health Announces Publication In Breast Cancer Research And Treatment Of Investigator-Initiated Phase 2 HALT-D Study Of Crofelemer For Prevention Of Chemotherapy-Induced Diarrhea In Breast Cancer Patients

By Benzinga Newsdesk

October 26, 8:51 AM

Results of the study provide the first proof-of-concept data for potential use of crofelemer - a novel, oral, plant-based, non-opioid antidiarrheal prescription medication - in breast cancer patients SAN FRANCISCO, CA /

JAGX

2 minute read

Anixa Biosciences Announces Commencement Of Phase 1b Trial Of Its Breast Cancer Vaccine At Cleveland Clinic

By Benzinga Newsdesk

October 26, 8:39 AM

Anixa Biosciences, Inc. (NASDAQ:ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, today announced the initiation of a Phase 1b trial for its

ANIX

3 minute read

Seres Therapeutics Announces FDA Acceptance Of Biologics License Application For Investigational Microbiome Therapeutic SER-109 For Recurrent C. Difficile Infection For Priority Review

By Benzinga Newsdesk

October 26, 7:09 AM

– If approved, SER-109 expected to be the first-ever FDA-approved oral microbiome therapeutic – – PDUFA target action date is April 26, 2023, with anticipated launch soon thereafter – –

MCRB

2 minute read

FDA
News

Immutep Announced Independent Data Monitoring Committee Positive Recommendation to Continue TACTI-003 Trial as Planned

By Charles Gross

October 26, 5:34 AM

Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces that the Independent Data Monitoring Committee (IDMC) for the randomised, controlled Phase IIb TACTI-003 trial has reviewed initial safety data and recommended continuing the trial with no modificatio

IMMP

4 minute read

Atara Biotherapeutics Presents New MRI And Updated Open-Label Extension Data From Phase 1 Study Of ATA188 In Progressive Multiple Sclerosis At ECTRIMS 2022 October 26-28

By Benzinga Newsdesk

October 26, 2:07 AM

Sustained Improvement Observed in ATA188 Treated Patients Achieving Confirmed Disability Improvement (CDI) in Open Label Extension (OLE) with up to 46 Months Follow up Patients Treated with ATA188 that Achieved CDI

ATRA

13 minute read

New Zeposia Data Highlight COVID-19 Outcomes And Preservation Of Long-Term Cognitive Function From Separate Analyses In Patients With Relapsing Forms Of Multiple Sclerosis

By Benzinga Newsdesk

October 26, 2:06 AM

Retrospective analyses from the Phase 3 DAYBREAK open-label extension study showed more than 90% of participants who received Zeposia mounted a serologic response to COVID-19 vaccination All adverse

BMY