Regulatory approval Archives

News and Trends 10 Nov 2022

Sanofi and GSK Covid-19 booster vaccine approved by European Commission

Sanofi and GSK’s Covid booster vaccine has been approved in Europe. After the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn Beta, the vaccine was approved by the European Commission, as a booster for the prevention of Covid-19 in adults 18 years of age and older. […]

November 10, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 26 Oct 2022

Singapore approves gas fermentation-powered protein

A food ingredient developed by the Finnish startup Solar Foods has earned its first market approval in Singapore. The product is brewed using microorganisms fed with carbon dioxide and electricity — a more sustainable alternative to conventional animal protein. Increasing numbers of fermentation-derived food products are reaching the market, including ingredients developed by Motif FoodWorks, […]

October 26, 2022 - 3 minutesmins - By Jonathan Smith

News and Trends 25 Oct 2022

Distributor of Curcugen and Ginfort receives dual natural product licenses

Two Health Canada natural product licenses have been achieved by DolCas Biotech LLC and have been found safe, effective and high quality. The products are its concentrated turmeric extract, Curcugen, and the other for Ginfort, a powerful ginger extract in powdered format. Produced by Olene Life Sciences, the two ingredient brands are research-backed for clinical […]

October 25, 2022 - 4 minutesmins - By Liza Laws

News and Trends 19 Oct 2022

Report says 20% of global cancer deaths could be avoided

A new study by members of the Bloomberg New Economy International Cancer Coalition says at least 1.5 million deaths from cancer could be avoided each year. This is 20% of the annual global deaths resulting from cancer. The study says this could happen if international regulations around patient trials were more standardized and people placed […]

October 19, 2022 - 6 minutesmins - By Jim Cornall

Caszyme crispr climate change Anastasiia Slynko

Interview 17 Oct 2022

CRISPR gene editing: a key tool for counteracting climate change

Monika Paulė, CEO and co-founder of the Lithuanian CRISPR developer Caszyme, explains how gene editing technology could fight climate change by boosting agriculture and biodiversity. The invention of CRISPR-Cas gene editing technology in the last decade sparked a revolution in biology, providing researchers a way to make selective and precise changes to an organism’s genetic […]

October 17, 2022 - 6 minutesmins - By Jonathan Smith

News and Trends 11 Oct 2022

Accelerated application for drug to help immunodeficiency submitted by Pharming

A marketing authorization application (MAA) has been submitted by Dutch company Pharming Group, to the European Medicines Agency (EMA) for a rare, primary immunodeficiency in adults and adolescents 12 years and older. Activated phosphonide 3-kinase delta syndrome (APDS), first discovered in 2013, is caused by genetic variants in either one of two identified genes known […]

October 11, 2022 - 4 minutesmins - By Liza Laws

News and Trends 3 Oct 2022

Poxel granted orphan drug designation for kidney disease treatment

French biopharma company Poxel SA says the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PXL770 for the treatment of patients with autosomal-dominant polycystic kidney disease (ADPKD). PXL770 is a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator – and is also a phase 2 ready ADPKD asset, subject […]

October 3, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 29 Sep 2022

Treatment for adults with chronic skin condition approved by FDA

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases […]

September 29, 2022 - 4 minutesmins - By Liza Laws

News and Trends 23 Sep 2022

Knockback for drug to treat patients with relapsed or refractory multiple myeloma

A Swedish biotech company says it believes its treatment could be the ‘canary in the coalmine’ despite a knockback. The Oncologic Drugs Advisory Committee (ODAC) has said it does not consider the treatment for patients with relapsed or refractory multiple myeloma (RRMM) favorable in a benefit-risk profile. Oncopeptides AB has been trialing Pepaxto in the […]

September 23, 2022 - 3 minutesmins - By Liza Laws

News and Trends 21 Sep 2022

FDA clears Cellenkos ALS drug for trial

Cellenkos, Inc., a clinical stage biotech company, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a phase 1 safety study followed by a phase 1b randomized, double blind, placebo control trial of CK0803, neurotrophic allogeneic Treg cells, in patients with amyotrophic lateral sclerosis […]

September 21, 2022 - 3 minutesmins - By Jim Cornall

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

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Regulatory approval

Sanofi and GSK Covid-19 booster vaccine approved by European Commission

Singapore approves gas fermentation-powered protein

Distributor of Curcugen and Ginfort receives dual natural product licenses

Report says 20% of global cancer deaths could be avoided

CRISPR gene editing: a key tool for counteracting climate change

Accelerated application for drug to help immunodeficiency submitted by Pharming

Poxel granted orphan drug designation for kidney disease treatment

Treatment for adults with chronic skin condition approved by FDA

Knockback for drug to treat patients with relapsed or refractory multiple myeloma

FDA clears Cellenkos ALS drug for trial

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

Treatment for adults with moderate to severe psoriasis approved by FDA

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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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Advertise with us

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