FDA Archives

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

News and Trends 5 Oct 2022

Transcenta monoclonal antibody gets FDA clearance

Transcenta Holding Limited says its TST004 humanized monoclonal antibody targeting MASP2, has received IND clearance from the U.S. Food and Drug Administration (FDA). MASP2, mannose-binding protein-associated serine protease 2, is a key enzyme in the lectin pathway initiation of complement activation. Studies have shown that lectin pathway activation contributes to multiple human diseases such as […]

October 5, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 4 Oct 2022

Aeglea BioTherapeutics updates homocystinuria program

Aeglea BioTherapeutics, Inc. says dosing in the third cohort of the phase 1/2 clinical trial of pegtarviliase for the treatment of classical homocystinuria is under way. Patients in this cohort are receiving 1.35 mg/kg of pegtarviliase once weekly administered via subcutaneous injection; patients in cohorts 1 and 2 received doses of 0.15 mg/kg and 0.45 […]

October 4, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 4 Oct 2022

FDA gives $1.3M grant to Biologics & Biosimilars Collective Intelligence Consortium

The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) has received a major grant from the Food & Drug Administration (FDA) in support of biosimilars research. The award provides $1.3 million over two years for a new BBCIC study focused on increasing the efficiency of biosimilar drug development and review. The study, “Improving the Efficiency of […]

October 4, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 3 Oct 2022

FDA clears Kira Pharmaceuticals’ phase 2 trial for SLE-TMA treatment

Kira Pharmaceuticals says the US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for KP104, a first-in-class bifunctional biologic that selectively and synergistically targets the alternative and terminal complement pathways. A phase 2 trial will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with […]

October 3, 2022 - 3 minutesmins - By Jim Cornall

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FDA

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

Transcenta monoclonal antibody gets FDA clearance

Aeglea BioTherapeutics updates homocystinuria program

FDA gives $1.3M grant to Biologics & Biosimilars Collective Intelligence Consortium

FDA clears Kira Pharmaceuticals’ phase 2 trial for SLE-TMA treatment

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Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

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Advertise with us

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