QRM Tools for Contract Biomanufacturing

Drug Solutions Podcast: Considering Biologic Drug Development and Manufacturing Holistically

Vimkunya was granted approval under priority review based on positive results from two Phase III trials.

Felicity Thomas

May 25th 2023

Podcast

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

Astellas’ IZERVAY Gets FDA Approval for Expanded Label to Treat Geographic Atrophy

FDA Approves GSK’s 5-in-1 Meningococcal Vaccine for Patients Aged 10 Through 25

This expanded label allows IZERVAY (avacincaptad pegol intravitreal solution) to be used without a limitation on duration of dosing for treating geographic atrophy.

FDA Approves Pfizer Combination Regimen for Treating R/R Diffuse Large B-Cell Lymphoma

The vaccine combines the antigenic components of two previously well-established meningococcal vaccines made by GSK.

February 14th 2025

Voyager Pauses IND Filing while Assessing Alternate Payloads for SOD1 ALS Gene Therapy Program

The approval of an ADCETRIS combination regimen is based on positive data from a Phase III trial where the combination regimen demonstrated a clinically meaningful reduction in the risk of death.

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

February 13th 2025

FDA Approves Bavarian Nordic’s Chikungunya Vaccine

The company plans to assess alternate payloads for its gene therapy program, which will shift its timeline.

Related Content

Drug Solutions Podcast: Considering Biologic Drug Development and Manufacturing Holistically

Vimkunya was granted approval under priority review based on positive results from two Phase III trials.

Felicity Thomas

May 25th 2023

Podcast

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Astellas’ IZERVAY Gets FDA Approval for Expanded Label to Treat Geographic Atrophy

FDA Approves GSK’s 5-in-1 Meningococcal Vaccine for Patients Aged 10 Through 25

This expanded label allows IZERVAY (avacincaptad pegol intravitreal solution) to be used without a limitation on duration of dosing for treating geographic atrophy.

FDA Approves Pfizer Combination Regimen for Treating R/R Diffuse Large B-Cell Lymphoma

The vaccine combines the antigenic components of two previously well-established meningococcal vaccines made by GSK.

February 14th 2025

Voyager Pauses IND Filing while Assessing Alternate Payloads for SOD1 ALS Gene Therapy Program

The approval of an ADCETRIS combination regimen is based on positive data from a Phase III trial where the combination regimen demonstrated a clinically meaningful reduction in the risk of death.

February 13th 2025