BioSpace News Archive

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FDA, NIH Accelerate Shift Away From Animal Research as Experts Warn of Limitations

The FDA and NIH recently announced plans to phase out animal testing requirements for some therapies. While organoid and AI providers celebrate, scientists warn that questions over safety, applicability and implementation remain.

May 19, 2025

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6 min read

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Natalia Mesa

COVID-19

FDA Grants Narrow Approval of Novavax’s COVID Shot as Makary Teases Changes to Vaccine Approval Framework

The restrictions on Novavax’s vaccine could portend changes at the FDA. Commissioner Marty Makary suggested last week that the agency could update its vaccine approval guidelines “in the coming days.”

May 19, 2025

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2 min read

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Tristan Manalac

Big fish eats small, takeover of the company. Art collage.

Mergers & acquisitions

Regeneron Comes to 23andMe’s Rescue With $256M Acquisition Plan

Regeneron promised to comply with 23andMe’s consumer privacy policies and related data security laws.

May 19, 2025

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2 min read

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Tristan Manalac

US Measles Outbreak and Increase in infection cases concept as a rising deadly outbreak disease and viral illness as a contagious chickenpox or a skin rash.

Policy

The Memory Gap: How Forgotten Diseases Are Making a Dangerous Comeback

In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.

May 19, 2025

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6 min read

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Lori Ellis

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Rare diseases

Applied Therapeutics’ Rare Disease Treatment Flunks in Late-Stage Trial

Govorestat failed to meet its primary endpoint in a Phase II/III trial for a rare form of Charcot-Marie-Tooth disease, a few months after the FDA rebuffed the same drug in a similar indication.

May 19, 2025

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2 min read

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Dan Samorodnitsky

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FDA

Makary’s ‘Conditional Approval’ Pathway for Rare Diseases Poses More Questions Than Answers

While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety, access and liability.

May 19, 2025

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10 min read

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Heather McKenzie

Alzheimer’s disease

FDA Clears First Alzheimer’s Blood Test, Lending ‘Momentum’ to Lilly’s Kisunla, Biogen’s Leqembi

Analysts at BMO Capital Markets said in a weekend note that a non-invasive blood test could help boost uptake of Alzheimer’s disease therapies.

May 19, 2025

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2 min read

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Tristan Manalac

Contemporary art collage. Human hands over dna drawings, looking at hereditary material. Medical university, studying genetics. Concept of healthcare, medicine, laboratory, awareness

Gene therapy

ASGCT Roundup: Sarepta, Rocket, Neurogene and the World’s First Tailored CRISPR Therapy

Taking center stage at the American Society of Gene and Cell Therapy meeting was the first-ever reported case of a personalized in vivo CRISPR editing therapy, which substantially eased the symptom burden in an infant.

May 19, 2025

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4 min read

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Tristan Manalac

Cardiovascular disease

Deep Dive: Checkpoint Inhibitors at a Crossroads

A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.

May 19, 2025

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2 min read

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Heather McKenzie

Circular handsaw cutting through a strip of red tape

Opinion

Slashing FDA Regulations Is Unlikely to Save Money for Industry

While the Trump administration has painted the jettisoning of staff and regulations as good for business, there are multiple reasons it’s unlikely to work out that way.

May 19, 2025

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4 min read

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Jessica Taylor