BioSpace News Archive

Robert Monroe, MD, PhD, is chief scientific officer of Oncology at Danaher Diagnostics and chief medical officer at Leica Biosystems.

Karan Arora

Karan Arora is senior vice president of Advanced Assays, AI, and Pharma Services at Leica Biosystems.

COVID-19

Moderna Wins Full Approval for COVID-19 Shot for Higher-Risk Kids

The approval of Moderna’s Spikevax for kids at higher risk of contracting the disease continues the company’s regulatory winning streak, which has also included nods for a next-gen COVID-19 vaccine and an RSV shot.

July 11, 2025

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2 min read

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Tristan Manalac

Contemporary art collage showing a hand giving a thumbs down surrounded by red arrows pointing down, concept of negative feedback and bad review

Complete response letters

Capricor Plunges on FDA Rejection of DMD Cell Therapy

In its complete response letter, the FDA cited insufficient evidence establish deramiocel’s effectiveness for cardiomyopathy associated with Duchenne muscular dystrophy. The decision comes after CBER Director Vinay Prasad canceled an advisory committee meeting for the therapy.

July 11, 2025

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3 min read

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Tristan Manalac

Person buried in paperwork hand raised collage art. Man drown in work concept. Overwork illustration for news banner, web articles, and posters

FDA

FDA Rejections: We Read 200 CRLs So You Don’t Have To

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli Lilly’s Alzheimer’s antibody Kisunla, Sarepta’s DMD gene therapy Vyondys 53 and Gilead’s HIV drug Sunlenca.

July 11, 2025

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5 min read

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Annalee Armstrong

Press Releases

Mirum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - July 10, 2025

July 11, 2025

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2 min read

Press Releases

Vera Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - July 10, 2025