BioSpace News Archive

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Opinion

Fate of FDA’s Laboratory-Developed Testing Final Rule Hints at Chevron Overturn’s Ramifications

In one of the first demonstrations of the impact of last year’s Loper Supreme Court decision on challenges to agency authority, a judge ruled that the FDA does not have authority to regulate tests developed by clinical laboratories.

September 29, 2025

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4 min read

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Megan Robertson

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FDA

Wall Street the Main Beneficiary of FDA’s Real-Time CRL Disclosures

By publishing complete response letters as soon as they are issued to drug sponsors, the FDA is expanding transparency in a way that, while positioned as a public health measure, also grants investors greater visibility into regulatory decisions. Experts question whether this is the agency’s proper remit.

September 29, 2025

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6 min read

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Ben Hargreaves

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Mergers & acquisitions

Genmab Buys Rising Cancer Star Merus for $8B

The centerpiece of the acquisition is petosemtamab, Merus’ bispecific antibody targeting EGFR and LGR5, which in May demonstrated best-in-class potential for head-and-neck cancer.

September 29, 2025

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2 min read

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Tristan Manalac

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Rare diseases

New Confirmatory Study Hints at ‘Alignment’ Between Applied Therapeutics, FDA for Rare Disease Drug

Applied Therapeutics has yet to confirm whether the study, posted on Clinicaltrials.gov on Thursday, means it has indeed aligned with the FDA on govorestat’s development.

September 29, 2025

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2 min read

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Tristan Manalac

Layoffs

Biogen Shuffles 20 Staff After Ending AAV Work

The AAV pullback comes amid Biogen’s aggressive cost-cutting campaign, which put some 1,000 jobs on the chopping block with the goal of generating $1 billion in savings by 2025.

September 29, 2025

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2 min read

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Tristan Manalac

FDA

September’s FDA Action Bolsters Keytruda, Ultra-Rare Disease but Deals Two SMA Defeats

The FDA in September issued two rejections for spinal muscular atrophy therapies—both linked to manufacturing problems—and granted approvals in Barth syndrome and for a subcutaneous version of Merck’s Keytruda that could be key to the blockbuster’s future earnings.

September 29, 2025

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10 min read

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Tristan Manalac

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Editorial

GSK CEO Emma Walmsley’s Departure Reseals Pharma’s Glass Ceiling

After Emma Walmsley steps down as GSK CEO in January, Vertex Pharma’s Reshma Kewalramani will be the sole female CEO at a top-20 pharma company. Still, there are many prominent women in pharma that could someday break through again.

September 29, 2025

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1 min read

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Annalee Armstrong

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Regulatory

6 FDA Decisions To Watch For in Q4

From more than 30 target action dates in the last three months of the year, BioSpace has narrowed the list to six regulatory decisions that could have far-reaching implications for biopharma and patients.

September 29, 2025

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9 min read

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Tristan Manalac