BioSpace News Archive

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FDA

Biotech leaders call for streamlining of INDs as FDA’s Trialblazer rolls out

The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won’t tip the scales much on its own.

August 3, 2026

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9 min read

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Jef Akst

Pipeline

5 companies advancing ATTR assets in the wake of Wainua’s fail

The Phase 3 failure of AstraZeneca and Ionis Pharmaceuticals’ antisense therapy in transthyretin amyloid cardiomyopathy last month left the space reeling—and readjusting. BioSpace looks at five contenders and where they currently stand.

August 3, 2026

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8 min read

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Tristan Manalac

Insights

Biologics push CMOs/CDMOs to expand sterile fill-finish and prefilled syringe capacity

As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic injectable market.

August 3, 2026

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2 min read

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Jennifer C. Smith-Parker

Press Releases

Leads Biolabs’ PD-L1/4-1BB Bispecific Antibody IND Application for Combination Therapy in Metastatic Colorectal Cancer Approved, Further Strengthening Gastrointestinal Oncology Franchise

August 3, 2026

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6 min read

Press Releases

XVIVO Granted Additional Patient Enrollment in the US PRESERVE CAP Study for XVIVO Heart Assist Transport