BioSpace News Archive

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Approvals

Axsome wins first non-antipsychotic FDA approval for Alzheimer’s agitation

Alzheimer’s disease agitation could mean peak sales of over $2.1 billion for Axsome’s Auvelity, according to analysts at William Blair.

May 1, 2026

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2 min read

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Tristan Manalac

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Earnings

Amgen positions MariTide as potential ‘best monthly’ obesity drug

Amgen has launched a late-stage program to test the feasibility of switching patients from weekly GLP-1 injections to its own investigational obesity asset MariTide, which could open up monthly or more infrequent dosing schedules.

May 1, 2026

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2 min read

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Tristan Manalac

Neurodegenerative disease

Corcept ties ALS drug to improved 2-year survival as Phase 3 start date nears

Corcept Therapeutics’ amyotrophic lateral sclerosis drug was linked to an 87% reduction in the risk of death, a result the biotech hopes to replicate in an upcoming Phase 3 trial.

May 1, 2026

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2 min read

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Nick Paul Taylor

Earnings

Moderna beats revenue expectations with $389M, but litigation dogs earnings

CEO Stéphane Bancel expressed confidence in Moderna’s first quarter, touting the revenue numbers as a sign of the company’s return to prosperity.

May 1, 2026

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3 min read

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Annalee Armstrong

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Manufacturing

Novartis unveils North Carolina API plant as final piece of $23B US expansion

The new plant will give Novartis end-to-end capabilities centered on North Carolina, where it plans to have five facilities across three sites.

May 1, 2026

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2 min read

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Nick Paul Taylor

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 taps Szarama as acting CBER director as Prasad’s tumultuous tenure ends

Katherine Szarama, who has served as Prasad’s deputy at the Center for Biologics Evaluation and Research since December, joins a long list of temporary leaders at the Department of Health and Human Services.

May 1, 2026

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2 min read

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Heather McKenzie

Press Releases

FibroBiologics Reports Q1 2026 Financial Results and Provides Corporate Update

May 1, 2026

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7 min read

Press Releases

TLX101-Px (Pixlumi®) MAA Accepted in Europe