FDA Archives - Page 208 of 220

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FDA
News

Immuron Announced US DoD Naval Medical Research Center Received feedback on IND Application for New Campylobacter ETEC Therapeutic; Said IND Does Not Contain Sufficient Information

July 26, 5:45 AM

:Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutic products for the prevention and treatment of gut pathogens, today announced that the US Naval Medical Research Center (NMRC) has received feedback from the US Food and Drug Administration following a review of the Investigational New Drug (IND) applica

IMRN

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Vaxxinity CEO Mei Mei Hu Speaking At White House Summit On Future of COVID-19 Vaccines

By Benzinga Newsdesk

July 25, 11:58 AM

Vaxxinity, Inc. (NASDAQ:VAXX) Chief Executive Officer Mei Mei Hu will participate as a speaker at the White House Summit on the Future of COVID-19 Vaccines. Hu is honored by the invitation and eager to engage in

VAXX

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HOOKIPA Gets FDA Nod For Initial-Stage Prostate Cancer Study

By Ragothaman Srinivasan

July 25, 11:49 AM

The U.S. Food and Drug Administration (FDA) has accepted HOOKIPA Pharma’s (NASDAQ: HOOK) Investigational New Drug (IND) application for HB-300, a novel arenaviral immunotherapy for the treatment of metastatic castration-resistant prostate cancer.

HOOK

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FDA Accepts AstraZeneca’s Submission For Low Breast Cancer Candidate Under Priority Review

By Ragothaman Srinivasan

July 25, 10:21 AM

The United States Food and Drug Administration (FDA) has accepted to review the supplemental Biologics License Application (sBLA) of AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo’s lead asset ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable

AZN

4 minute read

FDA
News

Athenex Announces Publication Of Data From Phase 3 Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel In Patients With Metastatic Breast Cancer In The Journal Of Clinical Oncology

By Benzinga Newsdesk

July 25, 10:02 AM

Athenex Announces Publication of Data from Phase 3 Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel in Patients with Metastatic Breast Cancer in the Journal of Clinical Oncology BUFFALO,

ATNX

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HOOKIPA Pharma Announces FDA Accepts Co.’s Investigational New Drug Application For HB-300 For The Treatment Of Metastatic Castration-resistant Prostate Cancer

By Benzinga Newsdesk

July 25, 8:03 AM

Novel arenaviral immunotherapy is directed against the prostate cancer targets PAP and PSA; Phase 1/2 trial to commence by early 2023 Drug Master File (DMF) accepted to support future FDA submissions

HOOK

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Veru Announces UK’s Medicines and Healthcare Products Regulatory Agency Supports Expedited Review of Marketing Authorization Application for Sabizabulin Treatment in Hospitalized COVID-19 Patients

By Benzinga Newsdesk

July 25, 7:31 AM

Veru Inc. (NASDAQ:VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced

VERU

2 minute read

Matinas BioPharma Announces Positive Opinion By The European Medicines Agency On Orphan Drug Designation For MAT2203 For The Treatment Of Cryptococcosis

By Benzinga Newsdesk

July 25, 6:31 AM

Matinas BioPharma (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of nucleic acids and small molecules with its lipid nanocrystal (LNC) platform

MTNB

2 minute read

Novartis’ Sandoz Unit Announced Applications for Proposed First-of-a-kind Multiple Sclerosis Biosimilar Natalizumab Accepted by US FDA and EMA

By Charles Gross

July 25, 5:27 AM

Sandoz, a global leader in generic and biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar natalizumab, developed by Polpharma Biologics.

NVS

3 minute read

FDA
News

AstraZeneca Announced Enhertu Granted Priority Review in the US for Patients with HER2-low Metastatic Breast Cancer

By Charles Gross

July 25, 4:55 AM

AstraZeneca and Daiichi Sankyo have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridisation [ISH]-negative) breast cancer who have received a prior therapy in the metastatic set

AZN