Regulatory approval Archives

News and Trends 19 Dec 2022

Jacobio’s cancer treatment given breakthrough therapy designations by China CDE

Jacobio Pharma’s in-house KRAS G12C inhibitor JAB-21822 has been granted breakthrough therapy designations in China. The designations are for the second line and above treatment of advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation. The designations were granted by the Center for Drug Evaluation (CDE) of the National Medical Products […]

December 19, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 16 Dec 2022

CSL closer to gene therapy treatments for hemophilia B patients in Europe

CSL says the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization (CMA) of etranacogene dezaparvovec. Etranacogene dezaparvovec is a one-time gene therapy for the treatment of appropriate adults with hemophilia B that reduces the rate of annual bleeds with a single infusion. […]

December 16, 2022 - 2 minutesmins - By Jim Cornall

In Depth 15 Dec 2022

To avoid stagnation, the EU must refine its ATMP regulation

Over the decades, the EU has spearheaded the adoption of advanced therapy medicinal products (ATMPs) such as cell and gene therapies. However, changes are needed to ATMP regulations to keep Europe competitive with the rest of the world. The EU has a rich resource base in terms of biotech innovation. Over the last decades, this […]

December 15, 2022 - 8 minutesmins - By Jonathan Smith

News and Trends 15 Dec 2022

European Commission approves Dupixent as first and only targeted prurigo nodularis medicine

The European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. 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 […]

December 15, 2022 - 5 minutesmins - By Jim Cornall

News and Trends 15 Dec 2022

EMA gives Myrtelle’s Canavan disease gene therapy candidate OD designation

Myrtelle Inc., a clinical stage gene therapy company, has announced that the European Medicines Agency (EMA) has granted orphan drug (OD) designation for rAAV-Olig001-ASPA, the company’s lead gene therapy product candidate for the treatment of Canavan disease (CD). EMA OD designation’s aim is to encourage the development of treatments for life-threatening rare conditions by providing […]

December 15, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 9 Dec 2022

Visiox Pharma announces FDA acceptance of glaucoma new drug application

Visiox Pharma, LLC has received notification from the U.S. Food and Drug Administration (FDA) that the agency has completed its filing review and accepted for filing the New Drug Application (NDA) for PDP-716 (0.35% brimonidine tartrate) for the treatment of glaucoma. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date […]

December 9, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 29 Nov 2022

Biocomposites antibiotic carrier, STIMULAN, receives approval for use in Mexico

UK-based medical devices company, Biocomposites Ltd., has announced that antibiotic carrier STIMULAN has received a new broad-based approval for use in bone and soft tissue in Mexico. The approval, granted by COFEPRIS, the Mexican Regulatory Authority, authorizes the use of STIMULAN as a carrier of substances such as antibiotics that are chosen by the surgeon […]

November 29, 2022 - 2 minutesmins - By Liza Laws

News and Trends 24 Nov 2022

Gene therapy approval “game changer” in hemophilia B treatment

The approval of CSL’s gene therapy Hemgenix has ushered in a new era for hemophilia B treatment. With the addition of other approvals like Rocktavian and Upstaza, 2022 could be a turning point for the broader gene therapy field. Earlier this week, etranacogene dezaparvovec (Hemgenix) made history as the first gene therapy approved by the […]

November 24, 2022 - 7 minutesmins - By Jonathan Smith

News and Trends 23 Nov 2022

FDA approves CSL gene therapy for hemophilia B

CSL has revealed that the U.S. Food and Drug Administration (FDA) has approved HEMGENIX (etranacogene dezaparvovec-drlb), the first and only one-time gene therapy for appropriate adults with hemophilia B. HEMGENIX is approved for the treatment of adults with hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage or […]

November 23, 2022 - 5 minutesmins - By Jim Cornall

News and Trends 18 Nov 2022

Novavax’ COVID-19 vaccine gets expanded authorization for booster in adults

Novavax, Inc., a U.S-based biotechnology company announced today (November 18) that Health Canada has granted expanded authorization for Covid-19 vaccine Nuvaxovid. The vaccine NVX-CoV2373 for active immunization to prevent the disease caused by severe acute respiratory syndrome (SARS-CoV-2) as a homologous booster in adults aged 18 and older. “Canadians now have access to our […]

November 18, 2022 - 2 minutesmins - By Liza Laws

News and Trends 14 Nov 2022

EpiEndo gets regulatory approval for first patient study of first non-antibiotic macrolide

EpiEndo Pharmaceuticals, a clinical-stage biopharma company developing therapeutics for chronic inflammatory diseases, has received regulatory approval to begin a phase 2a clinical trial. The trial will be with lead molecule EP395 in COPD (chronic obstructive pulmonary disease) patients, an orally available macrolide or ‘Barriolide,’ with reduced antimicrobial resistance potential. It aims to address the unmet […]

November 14, 2022 - 3 minutesmins - By Liza Laws

News and Trends 11 Nov 2022

Prurigo nodularis treatment recommended for EU approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent (dupilumab) in the European Union (EU) to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Dupilumab is being jointly developed by Sanofi and Regeneron. The European Commission is expected […]

November 11, 2022 - 3 minutesmins - By Jim Cornall

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Regulatory approval

Jacobio’s cancer treatment given breakthrough therapy designations by China CDE

CSL closer to gene therapy treatments for hemophilia B patients in Europe

To avoid stagnation, the EU must refine its ATMP regulation

European Commission approves Dupixent as first and only targeted prurigo nodularis medicine

EMA gives Myrtelle’s Canavan disease gene therapy candidate OD designation

Visiox Pharma announces FDA acceptance of glaucoma new drug application

Biocomposites antibiotic carrier, STIMULAN, receives approval for use in Mexico

Gene therapy approval “game changer” in hemophilia B treatment

FDA approves CSL gene therapy for hemophilia B

Novavax’ COVID-19 vaccine gets expanded authorization for booster in adults

EpiEndo gets regulatory approval for first patient study of first non-antibiotic macrolide

Prurigo nodularis treatment recommended for EU approval

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

Top biotech deals of February 2025

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These 7 biotechs are shaping the next generation of endometriosis care

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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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