Regulatory approval Archives

News and Trends 12 Sep 2022

Sensorion receives positive opinion from EMA for treatment of hearing loss

The European Medicines Agency (EMA) through its Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion for a treatment for otoferlin gene mediated hearing loss. Clinical-stage biotech, Sensorion, announced the news today (September 12) that its application for an Orphan Drug Designation (ODD) for its lead therapy gene candidate, OTOF-GT will now be […]

September 12, 2022 - 3 minutesmins - By Liza Laws

News and Trends 8 Sep 2022

Integral Molecular joins FDA’s ISTAND program

Integral Molecular has been accepted into the U.S. Food & Drug Administration (FDA)’s ISTAND (Innovative Science and Technology Approaches for New Drugs) pilot program. The program supports, and was created to expand, the drug development tool types listed in the 21st Century Cures legislation. A major goal of the pilot program is to qualify these […]

September 8, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 7 Sep 2022

Lytix Biopharma expanding advanced melanoma study to Europe

Lytix Biopharma, a Norwegian immuno-oncology company, has received regulatory approval from European authorities to start its ATLAS-IT-05 study in three European countries. ATLAS-IT-05 is a phase II combination study evaluating LTX-315 and pembrolizumab in patients with advanced melanoma. The study was initiated at MD Anderson Cancer Center in 2021 and is currently ongoing in the […]

September 7, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 5 Sep 2022

Avacta’s drug targeting soft tissue sarcoma granted Orphan Drug Designation by FDA

A drug to treat soft tissue sarcoma has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). Clinical stage oncology drug company Avacta Group plc has produced a form of the generic chemotherapy, doxorubicin AVA6000. About Avacta’s drug The drug has been modified using the company’s pre|CISION technology and Affirmer […]

September 5, 2022 - 2 minutesmins - By Liza Laws

News and Trends 2 Sep 2022

Psoriasis pustules disappear in over half of patients using Boehringer Ingelheim drug

More than half of patients treated for psoriasis with an intravenous injection showed no visible pustules just one week after receiving treatment. Boehringer Ingelheim announced today (September 2) that the U.S. Food and Drug Administration (FDA) has approved the first treatment option, SPEVIGO, for generalized pustular psoriasis (GPP) flares in adults. SPEVIGO is a novel, […]

September 2, 2022 - 2 minutesmins - By Liza Laws

News and Trends 1 Sep 2022

Sanofi’s first treatment in the U.S. approved for adults and children with ASMD

A rare, inherited disease that affects the body’s ability to metabolize fat, cholesterol and lipids within cells can now be treated by Xenpozyme, a drug approved by the U.S. Food and Drug Administration (FDA). Adults and children with non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) can now take healthcare company Sanofi’s Xenpozyme […]

September 1, 2022 - 4 minutesmins - By Liza Laws

acute respiratory distress syndrome pantherna therpeutics inflammatory lung disease

News and Trends 31 Aug 2022

Regulatory approval given to Iceland’s EpiEndo for study of COPD treatment

A treatment for chronic respiratory disorders will be the subject of a clinical trial in Iceland after regulatory and ethics approval was granted. EpiEndo Pharmaceuticals will start a clinical trial of its lipopolysaccharide challenge with lead molecule EP395. Available orally, EP395 is an macrolide or Barriolide with reduced antimicrobial activity which aims to address the […]

August 31, 2022 - 2 minutesmins - By Liza Laws

News and Trends 31 Aug 2022

United BioPharma gets FDA approval for phase 2 HIV drug trial

Taiwan-headquartered United BioPharma (UBP) says the U.S. Food and Drug Administration (FDA) has approved a phase 2 clinical trial IND submitted by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) of NIH. The purpose of the study is to assess the safety and antiviral activity of UB-421 in combination with optimized background ART […]

August 31, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 31 Aug 2022

Emactuzumab designated as an orphan medicinal product for TGCT in Europe

SynOx Therapeutics Limited says its novel monoclonal antibody, emactuzumab, in development for the treatment of tenosynovial giant cell tumor (TGCT) and other diseases, has been designated as an orphan medicinal product for both localized and diffuse types of the disease by the European Medicines Agency (EMA). No systemic treatments have been approved for TGCT in […]

August 31, 2022 - 4 minutesmins - By Jim Cornall

News and Trends 24 Aug 2022

Northwest Biotherapeutics’ pediatric investigation plan approved by MHRA

Northwest Biotherapeutics, a biotech company developing DCVax personalized immune therapies for solid tumor cancers, has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its pediatric investigation plan (PIP). The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for […]

August 24, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 22 Aug 2022

Drug to treat rare kidney disease to be reviewed by EMA

The European Medicines Agency (EMA) has agreed to review a conditional marketing authorization (CMA) application for a drug to treat a rare kidney disorder. The news was announced today (August 21) by CSL Vifor and Travere Therapeutics Inc, and, if approved, the companies say sparsentan will address a significant unmet need in treating IgA nephropathy […]

August 22, 2022 - 3 minutesmins - By Liza Laws

News and Trends 19 Aug 2022

Aeglea BioTherapeutics’ arginine 1 deficiency treatment gets EMA ok

Aeglea BioTherapeutics, Inc. says its marketing authorization application (MAA) for pegzilarginase for the treatment of arginase 1 deficiency (ARG1-D) has been validated by the European Medicines Agency (EMA). The MAA was submitted by Immedica Pharma AB, Aeglea’s commercialization partner in Europe and the Middle East. Pegzilarginase is a novel, recombinant human arginase 1 enzyme that […]

August 19, 2022 - 3 minutesmins - By Jim Cornall

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Regulatory approval

Sensorion receives positive opinion from EMA for treatment of hearing loss

Integral Molecular joins FDA’s ISTAND program

Lytix Biopharma expanding advanced melanoma study to Europe

Avacta’s drug targeting soft tissue sarcoma granted Orphan Drug Designation by FDA

Psoriasis pustules disappear in over half of patients using Boehringer Ingelheim drug

Sanofi’s first treatment in the U.S. approved for adults and children with ASMD

Regulatory approval given to Iceland’s EpiEndo for study of COPD treatment

United BioPharma gets FDA approval for phase 2 HIV drug trial

Emactuzumab designated as an orphan medicinal product for TGCT in Europe

Northwest Biotherapeutics’ pediatric investigation plan approved by MHRA

Drug to treat rare kidney disease to be reviewed by EMA

Aeglea BioTherapeutics’ arginine 1 deficiency treatment gets EMA ok

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Catalonia: A biotech hub going from strength to strength, with Barcelona at its core

Top biotech deals of February 2025

Grab your free report on 3D organoids and explore their future potential

These 7 biotechs are shaping the next generation of endometriosis care

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Catalonia: A biotech hub going from strength to strength, with Barcelona at its core

Top biotech deals of February 2025

Grab your free report on 3D organoids and explore their future potential

These 7 biotechs are shaping the next generation of endometriosis care

Connect with decision-makers and researchers worldwide for collaborative opportunities

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