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Asundexian’s Phase III win could also bode well for Bristol Myers Squibb, which is also developing a Factor XIa inhibitor called milvexian for stroke prevention, analysts said.
A source familiar with the matter said the White House initially requested the resignation of Sanjula Jain-Nagpal, a policy and research official at the FDA.
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.
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.
The regulator has received reports that a group of patients treated with Adzynma had neutralizing antibodies against the protein the therapy replaces.
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.
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.
After GSK subsidiary Tesaro filed a lawsuit Thursday claiming that AnaptysBio breached “certain requirements” under their 2014 license agreement involving GSK’s Jemperli, Anaptys responded Friday morning.
Amid an aggressive savings push, Moderna has cut three assets and taken on a loan to increase “flexibility.”
A new analysis from Jefferies shows that drugs receiving breakthrough designations sail through the regulatory process more quickly, on top of frequently winning approval.
The drugmaker’s dominance of the obesity market is fueling predictions that years of growth lie ahead.
Aspen is now also considering the possibility of an initial public offering next year in an effort to bring its cell therapy to the market.
PRESS RELEASES
• ASCO 2026: 2.5-Year Overall Survival Data • Jefferies Healthcare Conference: Partnering & Investor meetings • BIO International Convention: Panel Participation • MIB Agents Factor Osteosarcoma Conference: Data Presentation
The 6% naturally derived extract is set to be encapsulated for use in patients suffering from treatment-resistant depression under Australia’s Authorised Prescriber Scheme, where no serious adverse events have been reported as of December 2025
Live Presentation and Q&A: Thursday, May 28, 2026 12 PM EDT
• MustGrow has received approval from the agriculture departments of Texas, Utah, and Montana to commence sales of organic biofertility product TerraSanteTM. • Based on infield grower data, the mustard-derived TerraSanteTM biofertility product has been shown to improve crop yields, soil, and potentially the soil microbiome health for nutrient/water use efficiencies.
· Prof. Dr. med. Jürgen Braun joins the Scientific Advisory Board of MetrioPharm AG. · With more than 800 peer-reviewed publications and various prestigious awards, Prof. Braun is internationally recognized as a leading expert in the field of modern clinical and academic rheumatology.
Pharmaceutical service provider receives prestigious management award for the seventh year in a row · Family-owned company once again excels in all four key business areas · Site development and digitalization as strategic investment priorities · Focus on new sources for skilled workers and on lifelong learning
The upgraded platform offers a searchable database of over 300 risk-assessed HCPs, automated research scanning, and new flexible pricing options for mid-size drug developers.
New preprint by Jianghui Xiong, PhD, and the DeepoMe team introduces SteeraMed, a steerable biomedical world model for N-of-1 intervention reasoning across chronic diseases and aging