BioSpace News Archive

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Gene therapy

4 spaces primed for the next wave of gene therapies

The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.

May 18, 2026

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8 min read

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Andrea Park

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Opinion

FDA alignment is critical to serving the rare disease community. AI can help

The FDA has introduced models intended to accelerate rare disease drug development, but recent reversals of guidance from the agency speak to a lack of clarity in its implementation. AI can help focus this process.

May 18, 2026

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4 min read

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Rahul Gupta

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Cancer

Regeneron misses again as melanoma combo bows to Merck’s Keytruda in Phase 3

The late-stage miss shakes analyst confidence in Regeneron’s clinical execution, according to BMO Capital Markets, also noting last year’s Phase 3 failure in chronic obstructive pulmonary disease.

May 18, 2026

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2 min read

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Tristan Manalac

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Approvals

AstraZeneca wins nod for blood pressure pill, opening new class of hypertension drugs

Baxfendy, the first aldosterone synthase inhibitor to be approved by the FDA for high blood pressure, is among the products AstraZeneca is relying on to hit its 2030 goal of $80 billion in revenue.

May 18, 2026

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1 min read

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Tristan Manalac

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Deals

Regeneron, Parabilis set out to create new drug class in deal worth up to $2.3B

Right after reporting a major Phase 3 LAG-3 miss that has rattled analysts, Regeneron Pharmaceuticals revealed a back-loaded partnership with Parabilis Medicines aimed at adding a new drug class to its early-stage pipeline.

May 18, 2026

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2 min read

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Gabrielle Masson

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Drug Development

Is Revolution ‘the next oncology titan’? Truist analysts make the case

A month after reporting that its RAS inhibitor daraxonrasib doubled survival in advanced pancreatic cancer, Truist said Revolution Medicines “is evolving into a major revenue-generating oncology company,” and projects an approval in second-line disease by the end of the third quarter.

May 18, 2026

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3 min read

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Heather McKenzie

Pancreatic cancer

Can Revolution’s ‘miracle’ pancreatic cancer drug be topped? Immuneering, Actuate say yes

Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.

May 18, 2026

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7 min read

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Heather McKenzie

Obesity

Deep dive: The oral obesity wars

BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.

May 18, 2026

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3 min read

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Heather McKenzie

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Radiopharmaceuticals

The future of radiopharma is being built by nuclear geeks in SLC

Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.

May 18, 2026

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6 min read

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Annalee Armstrong

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Government

Prasad ally Szarama exits CBER after 3 weeks as FDA cleanout continues

After less than three weeks on the job, Katherine Szarama is being replaced by Karim Mikhail as acting head of the Center for Biologics Evaluation and Research. Mikhail had previously spent more than 20 years at Merck and joined the FDA last year.

May 18, 2026

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2 min read

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Tristan Manalac