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Opinion
Cell and Gene Therapy Will Transform Lives—If We Let It
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
November 24, 2025
·
8 min read
·
Tim Hunt
FDA
FDA Reversals Send UniQure, Biohaven, Capricor, More Into a ‘Tailspin’
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
November 24, 2025
·
7 min read
·
Heather McKenzie
Press Releases
Defence Therapeutics Announces Convertible Debenture Conversion
November 21, 2025
·
2 min read
Rare diseases
FDA Probing Patient Death Linked to Takeda’s Enzyme Replacement Therapy
The regulator has received reports that a group of patients treated with Adzynma had neutralizing antibodies against the protein the therapy replaces.
November 21, 2025
·
1 min read
·
Dan Samorodnitsky
Press Releases
Morphine Drugs Market Size to Hit USD 34.89 Billion by 2034
November 21, 2025
·
1 min read
Press Releases
New medical writing service provider QInscribe reduces the time to generate a draft Clinical Study Report (CSR) by 90% with Generative AI solution
November 21, 2025
·
1 min read
Regulatory
6 Biotechs With a Shot at the FDA’s Platform Technology Designation
After revoking Sarepta’s award in July and awarding one to Krystal last month, the FDA’s platform technology designation program appears to be back on track. These six biotechs could be on the regulator’s radar.
November 21, 2025
·
9 min read
·
Tristan Manalac
Layoff Tracker
Nurix Cuts Unknown Number of Employees Following Operational Review
Follow along as
BioSpace
tracks job cuts and restructuring initiatives.
November 21, 2025
·
91 min read
·
BioSpace Editorial Staff
AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services.
Multiple sclerosis
J&J, Contineum Fail ‘Risky’ Mid-Stage Multiple Sclerosis Trial
While expressing disappointment, William Blair analysts were unsurprised by the Phase II failure, having assigned the VISTA study a high level of risk given the “mixed” performance of a similar drug in a prior multiple sclerosis study.
November 21, 2025
·
2 min read
·
Tristan Manalac
1 of 86,506
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