Applying Operational Excellence Concepts to Biopharmaceutical Processing. Supplemental Tables. (PDF)

Two Samsung Bioepis Biosimilars Approved by Both FDA and EC

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

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

Ospomyv, or Obodence in the EU, and Xbryk were approved for all indications referencing Prolia and Xgeva, respectively.

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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.

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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.

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Two Samsung Bioepis Biosimilars Approved by Both FDA and EC

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

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

Ospomyv, or Obodence in the EU, and Xbryk were approved for all indications referencing Prolia and Xgeva, respectively.

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