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Regulatory
FDA Imposes Boxed Warning, Narrows Patient Pool for Sarepta’s Duchenne Gene Therapy Elevidys
Sarepta must also run a post-marketing study for Elevidys to better assess the risk of serious liver injury in patients dosed with the gene therapy.
November 17, 2025
·
1 min read
·
Tristan Manalac
Funding
Artios Pushes Cancer Pipeline Forward With $115M Series D
Artios Pharma is working on a pipeline of oncology assets, led by alnodesertib, currently being tested for second-line pancreatic cancer and third-line colorectal cancer.
November 17, 2025
·
1 min read
·
Tristan Manalac
Layoffs
Sensei Down to a Handful of Employees to Wrap Up Development Activities
Aside from announcing layoffs, Sensei has decided to terminate its R&D work. The biotech has $25 million on hand, and continues to evaluate its strategic alternatives.
November 17, 2025
·
2 min read
·
Tristan Manalac
Government
Signs of Frustration Build Between Kennedy and FDA Commissioner Makary
Signs of Frustration Build Between Kennedy, Makary
November 17, 2025
·
2 min read
·
Tristan Manalac
Layoff Tracker
BMS Hits New Jersey With Even More Layoffs; 110 Affected
Follow along as
BioSpace
tracks job cuts and restructuring initiatives.
November 17, 2025
·
85 min read
·
BioSpace Editorial Staff
Press Releases
4DMT Appoints Kristian Humer as Chief Financial Officer
November 17, 2025
·
3 min read
Press Releases
Anteris Technologies Presents Data from 100 DurAVR® THV Patients at PCR London Valves
November 17, 2025
·
6 min read
Press Releases
Zymeworks Announces Positive HERIZON-GEA-01 Phase 3 Results Supporting Ziihera® (zanidatamab-hrii) as HER2-Targeted Agent-of-Choice and New Standard of Care in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma
November 17, 2025
·
10 min read
Press Releases
High Dose Regimen of Nusinersen Receives Positive CHMP Opinion for the Treatment of Spinal Muscular Atrophy
November 17, 2025
·
13 min read
Press Releases
Henlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the US
November 17, 2025
·
19 min read
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