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Regulatory
After FDA Rejection, Lexicon’s Type 1 Diabetes Drug Hit With Another Regulatory Delay
An advisory committee last year found that Zynquista’s benefit-risk profile in type 1 diabetes was unfavorable due to cases of diabetic ketoacidosis.
September 23, 2025
·
1 min read
·
Tristan Manalac
Press Releases
VedaBio Announces Strategic Agreement with Siemens Healthineers and Series A Extension, Totaling Up to $25 Million
September 23, 2025
·
1 min read
Press Releases
FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent Indiana LLC Fill-Finish Facility
September 23, 2025
·
8 min read
Press Releases
New Study Highlights Urgent Need for RSV Prevention in Older Adults
September 23, 2025
·
4 min read
Press Releases
Triveni Doses First Subject in Global Phase 2 Proof of Concept Study of TRIV-509 in Atopic Dermatitis, Presents Translational Data at 2025 EADV Congress Demonstrating Novel Biology in Patient Samples
September 23, 2025
·
4 min read
Press Releases
New Subcutaneous Formulation of OPDIVO® Receives Positive INESSS Recommendation for Multiple Tumour Types
September 23, 2025
·
3 min read
Press Releases
Quest Diagnostics to Improve Laboratory Testing Experience with Industry-First Epic Collaboration
September 23, 2025
·
4 min read
Rare diseases
Ionis Heads to FDA As Antisense Therapy Aces Pivotal Study in Rare Neurological Disease
By improving gait stability, Ionis’ zilganersen could be “potentially disease modifying,” according to analysts at William Blair.
September 23, 2025
·
2 min read
·
Tristan Manalac
Press Releases
SEED Therapeutics Completes $30 Million Series A-3 Financing
September 23, 2025
·
2 min read
Press Releases
Transpire Bio’s ANDA for Generic Breo® Ellipta® Accepted for Filing By the U.S. FDA
September 23, 2025
·
2 min read
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