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The year may be coming to a close, but there’s no holiday break for the FDA, which will release five regulatory verdicts over the next two weeks.
Medicines on the list can still be prescribed but will be under tight monitoring by a regulatory network, which can implement measures to prevent shortages and ensure supply chain continuity.
Ahead of an expected surge in regulatory filings, the FDA is establishing the Genetic Metabolic Diseases Advisory Committee to provide advice on treatments for these complex and challenging conditions.
BioSpace and guests from Halia Therapeutics, Triumvira Immunologics and the Alzheimer’s Drug Discovery Foundation will discuss alternative financing strategies to consider for 2024. Watch now.
Even before its billionaire owner made recent headlines by endorsing an antisemitic post and hurling an expletive at advertisers, biopharma companies had begun to find different uses for their advertisement budgets.
Backed by ARCH Venture Partners and Fujifilm, as well as technology licensed from MIT, Tome is looking to create curative cell and integrative gene therapies.
In this episode we dive into regulation, real-time management, and AI’s various applications and how it can streamline different processes with guests from Microsoft and IQVIA.
As CAR T cell therapies attract significant biopharma investment, experts say there is plenty of space in the growing market for both treatments that use patients’ own cells and for those that rely on donor cells.
The companies have received all required regulatory approvals to complete the deal, the largest for the sector in the past three years and the biggest for the hot antibody-drug conjugate market.
The FDA decided last month to convene an advisory committee to discuss the companies’ proposed use of Abecma in earlier lines of treatment for multiple myeloma. Data presented Monday at the American Society of Hematology annual meeting provides a clue as to why.
With the acquisition, AstraZeneca will gain access to Icosavax’s investigational combination vaccine IVX-A12, which is being developed for respiratory syncytial virus and human metapneumovirus in older adults.
Bristol Myers Squibb has bought the rights to develop and commercialize SystImmune’s potentially first-in-class, bi-specific antibody-drug conjugate for lung and breast cancer as well as other solid tumors.