Daiichi Sankyo to Develop Thrombus Dissolving Agent

FDA Shake-Up: Vinay Prasad Exits Amid Tumult in Biologics Oversight

Germany-based biotech boosts animal-free supplement production, enabling greater scalability and supply security for next-gen cell therapies worldwide.

Resignation concept in a professional office setting | Image Credit: © Jane Kelly - stock.adobe.com

AstraZeneca’s Imfinzi Advances in Gastric Cancer With FDA Priority Review

Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash.

Pfizer Obtains Exclusive Rights to 3SBio’s Bispecific Antibody Targeting PD-1 and VEGF

Imfinzi’s application is supported by Phase III trial data showing improved pathologic complete response in early-stage gastric cancer.

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

Manufacturing and CMC Challenges in Immunotherapy: Lessons from Recent Complete Response Letters

The licensing agreement between the two companies gives Pfizer the rights to develop, manufacture, and commercialize 3SBio’s bispecific antibody, SSGJ-707, which is in clinical trials for the treatment of a variety of cancers.

Light bulb drawing as symbol of idea on chalkboard | Image Credit: © New Africa -stock.adobe.com

FDA Extends Review Period for GSK’s Blenrep

FDA’s recent CRLs for Replimune’s RP1 and others spotlight growing scrutiny on manufacturing, analytical rigor, and tech transfer in immunotherapy development.

PL BioScience Expands Cell Culture Manufacturing Capacity to Meet Global HPL Demand

The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.

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FDA Shake-Up: Vinay Prasad Exits Amid Tumult in Biologics Oversight

Germany-based biotech boosts animal-free supplement production, enabling greater scalability and supply security for next-gen cell therapies worldwide.

AstraZeneca’s Imfinzi Advances in Gastric Cancer With FDA Priority Review

Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash.

Pfizer Obtains Exclusive Rights to 3SBio’s Bispecific Antibody Targeting PD-1 and VEGF

Imfinzi’s application is supported by Phase III trial data showing improved pathologic complete response in early-stage gastric cancer.

Manufacturing and CMC Challenges in Immunotherapy: Lessons from Recent Complete Response Letters

FDA Extends Review Period for GSK’s Blenrep

FDA’s recent CRLs for Replimune’s RP1 and others spotlight growing scrutiny on manufacturing, analytical rigor, and tech transfer in immunotherapy development.