BioSpace News Archive

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Pfizer Is Not a Done Dealmaker After Metsera Buy, With $6B More To Spend

With $6 billion left in firepower, Pfizer is planning transactions in the hundreds of millions to the low-billions range, particularly in internal medicine and immunology and inflammation, Guggenheim reported.

December 10, 2025

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1 min read

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Annalee Armstrong

Podcast

Weight Loss Waves, Pazdur’s Exit and FDA Instability, New Neuro Breakthroughs

Pfizer deals again in obesity space as Wave and Structure drop splashy weight loss results; what CDER Director Richard Pazdur’s sudden retirement means for biopharma; neuro diseases take center stage at CTAD; and more.

December 10, 2025

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1 min read

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Heather McKenzie

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS).

Vaccines

FDA Launches Probe Into Safety of Approved Anti-RSV Antibodies

The FDA has informed Merck, Sanofi and AstraZeneca of the safety investigation into their RSV antibodies, though it remains unclear what regulatory action, if any, will be taken.

December 10, 2025

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2 min read

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Tristan Manalac

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Rare diseases

FDA Greenlights First Gene Therapy for Rare Pediatric Disease

Backed by Italy-based Fondazione Telethon ETS, Waskyra, for Wiskott-Aldrich syndrome, is the first gene therapy from a non-profit sponsor to win FDA approval.

December 10, 2025

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1 min read

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Tristan Manalac

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Approvals

First Commissioner’s Priority Review Approval Goes to Decades-Old Antibiotic

The Commissioner’s National Priority Voucher program was launched in June to shorten review times for companies that align with various national priorities, such as improving domestic drug production and supply.

December 10, 2025

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2 min read

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Tristan Manalac

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Japan

Japanese Pharmas Looking Beyond Borders for M&A to US, EU

Long a quieter, locally focused industry, Japanese pharma giants are increasingly looking to the rest of the world for deals.

December 10, 2025

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7 min read

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Dan Samorodnitsky

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Regulatory

Regeneron Climbs Back After a Year of Regulatory, Manufacturing Misery

After a series of unfortunate regulatory rejections and manufacturing issues surfaced, Regeneron’s shares dipped to $483 this summer—the lowest they’d been since early 2021. But they now sit higher than they did at the start of the year.

December 10, 2025

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3 min read

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Annalee Armstrong

Press Releases

Phillips Medisize Highlights Inhaled Drug Delivery Device Platforms and Scientific Insights at DDL 2025

December 10, 2025

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4 min read

Press Releases

Regenerative Patch Technologies (RPT) Announces Treatment of First Two Patients in Phase IIb Clinical Trial Assessing the Safety and Efficacy of its Allogeneic Bioengineered RPE Cell Implant for the Treatment of Advanced Dry Age-Related Macular Degeneration.