BioSpace News Archive

Year

• 2005
• 2006
• 2007
• 2008
• 2009
• 2010
• 2011
• 2012
• 2013
• 2014
• 2015
• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

Month

• January
• February
• March
• April
• May
• June
• July
• August
• September
• October
• November
• December

Day

• 2
• 3
• 4
• 5
• 6
• 9
• 10
• 11
• 12
• 13
• 16
• 17
• 18
• 19
• 20
• 23
• 24
• 25
• 26
• 27
• 30

• 

  IN PARTNERSHIP WITH IQVIA

  AI’s Role in Decoding the FDA’s New Regulatory Communications

  In this episode of Denatured, presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses how AI transformation can help organizations navigate a rapidly evolving regulatory environment with senior director of regulatory innovation and technology, Michelle Gyzen.

  June 5, 2025

   · 

  1 min read

   · 

  Lori Ellis
• 

  Autoimmune disease

  Cullinan Bets $700M+ in Back-Heavy China Deal for Autoimmune T Cell Engager

  Genrix’s velinotamig complements Cullinan’s own pipeline, according to William Blair, which added that the deal will put Cullinan in a better position to target autoimmune diseases.

  June 5, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Gene therapy

  Sarepta Wins FDA’s Platform Technology Designation, Marking ‘Critical Shift’ in Gene Therapy Development

  The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug development and review process, particularly for rare diseases.

  June 5, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Government

  Fired HHS Staff Sue RFK Jr., Musk, Claiming Terminations Were Based on ‘Error-Ridden’ Information

  The lawsuit alleges that HHS leadership knew the records they used to guide their layoff decisions were inaccurate and contained errors.

  June 5, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Duchenne muscular dystrophy

  Regenxbio Fails To Best Sarepta’s Elevidys With New Data for DMD Gene Therapy

  Interim results from a small group of children in a Phase I/II trial are essentially in line with that of Elevidys, according to BMO Capital Markets analysts.

  June 5, 2025

   · 

  2 min read

   · 

  Dan Samorodnitsky
• 

  Huntington’s disease

  UniQure’s Regulatory Progress Sparks Optimism for ‘Desperate’ Huntington’s Space

  Analysts reacted positively to the news that uniQure is in alignment with the FDA on an accelerated approval pathway and on target for a Q1 2026 submission for its one-time gene therapy for Huntington’s disease—but patients have been here before.

  June 5, 2025

   · 

  6 min read

   · 

  Heather McKenzie
• Press Releases

  Philips announces exchange ratio for 2024 dividend

  June 5, 2025

   · 

  2 min read
• Press Releases

  CancerVax Achieves Major Milestone with Successful Creation of Cell Targeting Nanoparticle

  June 5, 2025

   · 

  4 min read
• Press Releases

  Hengrui Pharma Showcases Global Impact at the 2025 ASCO: 72 Study Results Highlight Chinese Cancer Innovation

  June 5, 2025

   · 

  3 min read
• Press Releases

  Osivax Announces Last Patient Last Visit in Phase 2a Trial Evaluating a Booster Dose of Broad-Spectrum Influenza Vaccine OVX836 s release

  June 5, 2025

   · 

  3 min read