FDA Archives

More News! 14 Nov 2022

BioSenic’s autoimmune disease platform adapting to meet unmet medical needs

BioSenic’s systemic autoimmune disease platform, originally designed by Medsenic, is now developing controlled dosages and new formulations adapted to a significant number of important indications with unmet medical needs. BioSenic specializes in serious autoimmune and inflammatory diseases as well as cell repair. The update follows the announcement of the merger between Bone Therapeutics and Medsenic […]

November 14, 2022 - 4 minutesmins - By Liza Laws

News and Trends 14 Nov 2022

New therapy transitions toxic immune cells from harmful to healing to fight effects of hyperinflammation in children

When we think about acute kidney injury (AKI) and multi-organ failure, we don’t often think about children. But approximately 4,000 pediatric patients in the U.S. each year have AKI requiring continual kidney replacement therapy (CKRT). These patient profiles are associated with long hospital stays, high morbidity and mortality (50%), and children who survive an AKI […]

November 14, 2022 - 5 minutesmins - By Jim Cornall

More News! 8 Nov 2022

JelloX Biotech helps doctors diagnose and treat cancer tumors with speed and accuracy

Taiwan-based start-up, JelloX Biotech, says its products will help doctors diagnose and treat cancer tumors with speed and accuracy without an added strain on budgets. The company made its debut at Intel Innovation in September. JelloX has gained the attention of healthcare experts and pharmaceutical brands for its potential for the future of cancer pathology using […]

November 8, 2022 - 3 minutesmins - By Liza Laws

News and Trends 8 Nov 2022

MedinCell’s partner AIC registers trial for drug for total knee replacement pain

A partner of MedinCell, Arthritis Innovation Corporation (AIC), has registered a phase 3 trial to look into an alternative drug to deal with pain after total knee replacement (TKR). Arthritis Innovation Corporation conducts and finances all development activities of the drug F14, or mdc-CWM, being trialed. It was registered with the safety and efficacy study […]

November 8, 2022 - 3 minutesmins - By Liza Laws

More News! 7 Nov 2022

Sensorion granted rare pediatric disease designation by FDA for lead therapy gene

Sensorion has announced that the US Food and Drug Administration (FDA) has granted rare pediatric disease designation to its lead therapy gene candidate, OTOF-GT. The gene therapy is intended for the treatment of otoferlin gene mediated hearing loss. Sensorion’s OTOF-GT gene therapy development program aims to restore hearing in people living with otoferlin deficiency, one […]

November 7, 2022 - 2 minutesmins - By Liza Laws

News and Trends 7 Nov 2022

TMRW Life Sciences FDA-approved tech will help more people start families

Fertility technology company, TMRW Life Sciences Inc., has received FDA clearance for its latest technology that will help more people build families. The CryoRobot Select marks the latest milestone in the company’s expansion of its technology-enabled portfolio. USA-based TMRW says advances like theirs in assisted reproductive technology are helping people start families when they otherwise […]

November 7, 2022 - 3 minutesmins - By Liza Laws

News and Trends 20 Oct 2022

Partnership formed to make drug for MoCD Type A available sooner

Inceptua Early Access and Sentynl Therapeutics Inc., a U.S.-based biopharmaceutical company bringing therapies to patients living with rare diseases, have entered into a partnership. The partnership is to make Sentynl’s Nulibry available via an early access program for eligible patients with molybdenum cofactor deficiency (MoCD) Type A. MoCD Type A is a rapidly progressive autosomal […]

October 20, 2022 - 2 minutesmins - By Liza Laws

brain cancer glioblastoma divide and conquer

News and Trends 20 Oct 2022

Healthy volunteer study for tablet to treat brain cancer open for recruitment

A clinical stage drug company developing sulforaphane-based medicines for cancer treatment has started recruiting for a pharmacokinetic / pharmacodynamic trial in healthy volunteers (HV). Evgen Pharma plc also announced the start an investigator sponsored clinical study (ISS) for a glioblastoma program. The purpose of the HV study is to examine the performance of Evgen’s new […]

October 20, 2022 - 4 minutesmins - By Liza Laws

News and Trends 13 Oct 2022

Plan launched to improve diversity of clinical trials

Help to improve the equity of clinical trials by providing site-level participant demographic data including race, sex, age and ethnicity has been revealed. Medidata, a Dassault Systèmes company, has launched the intelligent trials diversity module. The new module will help sponsors and clinical research organizations (CROs) benchmark the diversity of their trials and identify sites […]

October 13, 2022 - 3 minutesmins - By Liza Laws

News and Trends 12 Oct 2022

Boston Cell Standards wins FDA $510K clearance for anatomic pathology controls

A company standardizing cancer diagnostic tissue testing with the first immunohistochemistry (IHC) laboratory reference standards has received $510,000 clearance from the U.S. Food and Drug Administration (FDA). The money will go towards Boston Cell Standards IHControls panel for evaluating breast cancers. The clearance represents regulatory approval. “IHControls represent a giant step forward in standardization in […]

October 12, 2022 - 2 minutesmins - By Liza Laws

News and Trends 12 Oct 2022

SiSaf takes steps with FDA for RNA therapeutic to treat rare genetic skeletal disorders

SiSaf Ltd, an RNA delivery and therapeutics company, is initiating the U.S. FDA Regulatory process to obtain orphan drug designation for SIS-101-ADO. SIS-101-ADO is a siRNA therapeutic for patients with autosomal dominant osteopetrosis type 2 (ADO2), a rare genetic skeletal disorder. The request for orphan drug designation and advancement through the regulatory process that SIS-101-ADO […]

October 12, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 5 Oct 2022

FDA fast tracks Immutep non-small cell lung cancer candidate

Immutep Limited says the United States Food and Drug Administration (FDA) has granted fast track designation to eftilagimod alpha (efti or IMP321) in combination with pembrolizumab for the treatment of first line non-small cell lung cancer (NSCLC). Efti is the company’s first-in-class soluble LAG-3 clinical stage candidate, which activates antigen presenting cells (APC) to engage […]

October 5, 2022 - 3 minutesmins - By Jim Cornall

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Webinar: Organoids in cancer research - Paving the way for faster drug development across cancer indications

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FDA

BioSenic’s autoimmune disease platform adapting to meet unmet medical needs

New therapy transitions toxic immune cells from harmful to healing to fight effects of hyperinflammation in children

JelloX Biotech helps doctors diagnose and treat cancer tumors with speed and accuracy

MedinCell’s partner AIC registers trial for drug for total knee replacement pain

Sensorion granted rare pediatric disease designation by FDA for lead therapy gene

TMRW Life Sciences FDA-approved tech will help more people start families

Partnership formed to make drug for MoCD Type A available sooner

Healthy volunteer study for tablet to treat brain cancer open for recruitment

Plan launched to improve diversity of clinical trials

Boston Cell Standards wins FDA $510K clearance for anatomic pathology controls

SiSaf takes steps with FDA for RNA therapeutic to treat rare genetic skeletal disorders

FDA fast tracks Immutep non-small cell lung cancer candidate

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Webinar: Organoids in cancer research - Paving the way for faster drug development across cancer indications

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Webinar: Organoids in cancer research - Paving the way for faster drug development across cancer indications

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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