Regulatory approval Archives

News and Trends 19 Sep 2022

FDA approves Heron Therapeutics’ post-op nausea and vomiting drug

Heron Therapeutics, Inc. says the U.S. Food and Drug Administration (FDA) has approved APONVIE (aprepitant) injectable emulsion, for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults. Heron Therapeutics’ APONVIE is the first and only IV formulation of aprepitant for PONV prevention. Administered via a single 30-second IV injection, APONVIE reaches […]

September 19, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 12 Sep 2022

Treatment for adults with moderate to severe psoriasis approved by FDA

A treatment for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy has been approved by the U.S. Food and Drug Administration (FDA). Bristol Myers Squibb made the announcement today (September 12) that its allosteric tyrosine kinase 2 (TYK2) inhibitor, Sotyku (deucravacitinib) had been approved based on results from a phase […]

September 12, 2022 - 3 minutesmins - By Liza Laws

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

Knowledge hub

Categories

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Approaches

Therapeutic areas

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

R&D

BD

World biotech leaders

Connect with decision-makers and researchers worldwide for collaborative opportunities

Company

Join Us

Subscribe to our newsletter

Advertise with us

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Regulatory approval

FDA approves Heron Therapeutics’ post-op nausea and vomiting drug

Treatment for adults with moderate to severe psoriasis approved by FDA

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

Subscribe to our newsletter to get the latest biotech news!

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Subscribe to our newsletter

Get the latest biotech news directly to your inbox!

Newsletter Signup - Footer

Subscribe to our newsletter to get the latest biotech news!