BioSpace News Archive

Press Releases

Study Reveals Alarming Number of Invasive Breast Cancers in Younger Women

December 1, 2025

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4 min read

Press Releases

FDA Approves IsoPSA® -- Cleveland Diagnostics’ Novel Blood-Based Prostate Cancer Test

December 1, 2025

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3 min read

Office worker, employee being late for work, looking untidy. Deadlines and time management. Contemporary art collage. Concept of business, office lifestyle, career, challenges

FDA

FDA Delays Decision on Ascendis’ Dwarfism Drug by Three Months

If approved, Ascendis’ TransCon CNP would become the second therapy for achondroplasia, challenging BioMarin’s Voxzogo.

December 1, 2025

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1 min read

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Tristan Manalac

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’s Prasad Links 10 Child Deaths to COVID-19 Vaccines, Eyes Stricter Review Guidelines

The alleged deaths were detected by the FDA’s Vaccine Adverse Event Reporting System, reports from which “generally cannot be used to determine” causation or even contribution, according to the agency.

December 1, 2025

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2 min read

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Tristan Manalac

Creative sketch collage of business people handshake gesture approval project development success colleagues cooperation support.

Gene editing

Regeneron Makes $275M Gene Editing Play With Tessera Partnership Targeting AATD

The centerpiece of the deal is the in vivo editor TSRA-196, which in preclinical studies has shown robust editing at SERPINA1, the locus linked to alpha-1 antitrypsin deficiency.

December 1, 2025

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1 min read

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Tristan Manalac

A piggy bank crammed with $100 bills on a background of American cash

Series B

Novartis-Backed Protego Eyes Pivotal Amyloidosis Study With $130M Series B

Protego Biopharma is advancing a small-molecule drug that helps light chain proteins fold correctly, in turn addressing the underlying biological cause of AL amyloidosis.

December 1, 2025

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1 min read

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Tristan Manalac

Insulin syringe pens wrapped in dollar bills on a blue background. Pharmaceutical monopolists raise drug prices. Top view with copy space

Drug Delivery

Lilly Cuts Zepbound Prices, Again, When Buying Through DTC Program

Following Novo Nordisk’s price cuts for its own GLP-1 medicines, Eli Lilly is offering discounts for the obesity drug purchased through LillyDirect. Both pharmas recently struck a deal with the White House for cheaper prices via the yet-to-be-launched TrumpRx.

December 1, 2025

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1 min read

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Dan Samorodnitsky

Press Releases

Biolexis Therapeutics VP of Clinical Development Selected for Dual Featured Presentations at the 2nd Innovation in Obesity Therapeutics Summit

December 1, 2025

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1 min read

Press Releases

BioMark Diagnostics Collaborative Lung Cancer Screening Project Honored by ADRIQ during the 35th Innovation Awards Gala