Latest News
& Press Releases
Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
TOP STORIES
Health Secretary Robert F. Kennedy Jr. has become increasingly unpopular among several government officials, largely as a result of his antivaccine rhetoric and actions. Other contentious issues reportedly include the approval of an abortion pill and other controversial FDA decisions.
Sana Biotechnology is looking to start clinical development for its type 1 diabetes therapy SC451 this year.
The Hunter syndrome space suffered a setback in February when the FDA turned down REGENXBIO’s investigational gene therapy, raising urgent questions about whether competitor Denali Therapeutics can clear the agency’s bar next month.
As the Formula 1 season kicks off in the APAC region, biopharma companies can take a page from the popular sport’s playbook around precision, adaptability, and the right team. In return, biopharma can also offer some lessons to elite motor sport on well-rounded excellence in the race to market.
Dozens of biotechs reported earnings this week. BioSpace recaps key highlights from Capricor Therapeutics, Legend Biotech, Inovio and Allogene.
While requests by government officials for anonymity when speaking to the media are nothing new, the practice attracts more scrutiny when the Department for Health and Human Services has pledged a commitment to “radical transparency.”
Solid Biosciences’ SGT-003 is the only late‑stage program to show early cardiac benefit across biomarkers and function, according to William Blair.
Small-molecule drugs account for nearly half of the most valuable investigational therapies for orphan diseases, according to analytics firm Evaluate.
After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance aims to standardize the practice. But recent decisions call into question whether shared evidence and prior knowledge will accelerate development in rare diseases.
Total assets under management for Novo Holdings, Novo Nordisk’s controlling shareholder, fell by more than one-third last year. The report caps off a tumultuous year for the Novo group of companies.
Combining tirzepatide with vitamin B12, a common additive in compounded versions of the drug, yields an impurity that could alter the drug’s toxicity profile and pose safety risks to patients, the company said in an open letter.
Data from BridgeBio Pharma’s Phase 3 FORTIFY study show that BBP-418 significantly increases levels of a key disease biomarker that helps stabilize muscles in patients with limb-girdle muscular dystrophy.
PRESS RELEASES
Received FDA approval to expand fully implanted Acclaim® Cochlear Implant Pivotal Clinical Trial to final stage Strengthened balance sheet by extinguishing $32 million in debt Subsequent to year-end, closed on transformational capital raise led by established institutional healthcare investors and completed enrollment of Pivotal Clinical Trial for first-of-its-kind fully implanted cochlear implant
Prestigious Late-Breaking Research Session Positions PH-762 as a Promising New PD-1 Directed Immunotherapy Candidate on March 28, 2026 at 3 PM (MDT)
• Human Organoid Data Supports the Therapeutic Rationale for INM-901 Program Ahead of Human Clinical Trials • Consistent Anti-Inflammatory Effects Demonstrate Translation from Animal Models to Three-Dimensional Human Brain Tissue Systems
This novel whole-body insulin-sensitizing approach is designed to address insulin resistance independent of weight loss