Biotech Archives - Page 768 of 795

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Soligenix Partners With SERB Pharmaceuticals To Supply Ricin Antigen For Ricin Toxin Poisoning Treatment

July 25, 9:16 AM

Soligenix Inc (NASDAQ:SNGX) has signed a worldwide license to supply its ricin antigen to SERB Pharmaceuticals for novel therapeutic treatment against…

SNGX

2 minute read

IceCure Announces Regulatory Filing Submission For Approval Of ProSense In Canada For Indications Including Ablation Of Benign And Malignant Breast Tumors

By Bill Haddad

July 25, 8:05 AM

Canadian hospitals and health care providers have expressed strong interest in ProSense® as they seek minimally invasive treatments for breast and other tumors CAESAREA, Israel, July 25, 2022 /PRNewswire/

ICCM

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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

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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

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Europe’s CHMP Recommends Approving AstraZeneca’s Asthma, Neuromuscular Disorder Treatments

By Vandana Singh

July 25, 6:27 AM

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AstraZeneca Plc’s (NASDAQ:AZN) Ultomiris (ravulizumab)…

AZN

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First Case Of Monkeypox In Japan Detected In Tokyo

By Benzinga Newsdesk

July 25, 6:27 AM

- Reuters

AEMD

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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

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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

2 minute read

AstraZeneca Announced Ultomiris Recommended for Approval in the EU by CHMP for the Treatment of Adults with Generalized Myasthenia Gravis

By Charles Gross

July 25, 4:53 AM

Ultomiris (ravulizumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

AZN