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February 6th, 2026
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FDA Grants Priority Review for Pfizer’s HYMPAVZI

 
FDA Grants Priority Review for Pfizer’s HYMPAVZI

Submission aims to expand HYMPAVZI indication to the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients without inhibitors.
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ADARx Pharmaceuticals Appoints Donald Fong as CMO

Fong most recently served in the same capacity for BioCryst Pharmaceuticals.

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[VIDEO] Inside the Future of CDMO Partnerships

GRAM's VP of Quality and Regulatory discusses the industry's expectations of CDMOs in today’s market and advancing to support evolving needs.

Financial News

Sanofi 4Q Results

Revenues up 7% in the quarter despite €801 million loss.

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Collaborations & Alliances

Eisai, Henlius Strike Japan Commercialization Deal for PD‑1 Antibody Serplulimab

Under the terms of the agreement, Eisai will obtain exclusive rights to commercialize serplulimab in Japan.

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Tackling Biologics Manufacturing: From Standard to Complex

A resource to help biopharma teams overcome complexity and streamline operations without sacrificing product quality.

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Trials & Filings

AbbVie Submits Regulatory Applications for Rinvoq in Patients with Vitiligo

If approved, upadacitinib will be the first systemic medication available for patients with vitiligo.

Best Practices in Oral Solid Dose Drug Distribution

Ensuring quality, compliance and patient-centric operations with robust processes and innovative solutions.

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A New World is One Molecule Away

gChem, formerly Gaylord Chemical Company LLC, is the nation’s premier manufacturer and world’s leading innovator of DMSO, providing optimal solutions for diverse industries that are unmatched in quality and safe for people and planet.

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Solution Content Centers SPOTLIGHT

Adare Pharma Solutions

Adare Pharma Solutions is a global technology-driven CDMO providing end-to-end integrated services, from product development through commercial manufacturing and packaging, with small molecule expertise focusing on oral dosage forms. Adare’s specialized technology platforms provide taste masking, customized release, multiparticulate systems, and patient-centric dosing solutions. With a proven history in drug delivery, Adare’s facilities in the US and Europe have developed and manufactured more than sixty-five products sold by customers worldwide.

 

Solution Content Centers SPOTLIGHT

Solvias

Solvias is a global provider of CMC analytics to the pharmaceutical and biotech industry. Our expert teams combine 25 years of experience with regulatory understanding across small molecules, biologics, and cell and gene therapies. We offer comprehensive solutions from raw materials to drug substance & product to final release testing.