BioSpace News Archive

factory of the pharmaceutical industry. pills on the conveyor

Manufacturing

Drugmakers Push FDA To Extend Support to Existing Facilities

Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.

November 11, 2025

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4 min read

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Nick Paul Taylor

Changing or transforming, turning around, challenging the odds and conquering adversity, a businessman pole vaulting from the down arrow to the up arrow of growth

Cancer

Cogent Hits ‘Unprecedented’ Efficacy in Rare Stomach Cancer, Clearing Path to FDA

Cogent Biosciences expects to file a new drug application for bezuclastinib in gastrointestinal stromal tumors early next year after what Leerink said was “the first positive trial in this disease in over a decade.”

November 11, 2025

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2 min read

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Tristan Manalac

Depression

Neurocrine’s Depression Drug Delivers ‘Surprise’ Phase II Miss

The mid-stage failure was unexpected to analysts at BMO Capital Markets, who viewed ‘770 as mostly derisked given its similar mechanism of action to Johnson & Johnson’s Spravato.

November 11, 2025

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2 min read

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Tristan Manalac

3d rendering medical heart in yellow background

Cardiovascular disease

Amgen, Merck, Novo, More Take Cardiovascular Benefits to New Heights at AHA 2025

Data presented at this year’s American Heart Association Scientific Sessions in New Orleans underline rapid advancements in the cardiovascular field.

November 11, 2025

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5 min read

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Tristan Manalac

Silver Spring, MD, USA 11/10/2020: Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medications, vaccines and food additives for human use.

FDA

FDA Stalwart Pazdur Named Tidmarsh’s Replacement as CDER Director

The appointment of Richard Pazdur, currently director of the FDA’s Oncology Center of Excellence, comes less than a week after he reportedly declined the post, and just nine days after his predecessor’s controversial exit.

November 11, 2025

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1 min read

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Heather McKenzie

Press Releases

DISTINGUISHED CANCER RESEARCHER STUART S. MARTIN, PHD, NAMED CHAIR OF THE DEPARTMENT OF PHARMACOLOGY & PHYSIOLOGY AT UM SCHOOL OF MEDICINE

November 11, 2025

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7 min read

Press Releases

Vistagen to Report Fiscal Year 2026 Second Quarter Results and Host Corporate Update Conference Call on November 13, 2025