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
Aside from its manufacturing and distribution footprint, ITM Isotope Technologies Munich will give Telix Pharmaceuticals the late-stage ITM-11, being developed for gastroenteropancreatic neuroendocrine tumors. The asset was rejected by the FDA last month for manufacturing concerns.
Investors and analysts have been hounding Novo to beef up its pipeline and advance new molecules as a majority of the company’s sales stem from its semaglutide franchise.
Delivering therapeutics directly to tumors, as in the case of Replimune’s recently approved Tudriqev and Amgen’s Imlygic, holds advantages, especially when cancer is caught early, but challenges remain before the method becomes a mainstay in treatment.
Newly permanent CBER and CDER directors Karim Mikhail and Michael Davis are widely expected to continue the FDA’s efforts toward an adaptive framework for rare disease therapies. If approved by the Senate, will commissioner nominee Heidi Overton stay the course?
As molecule complexity rises, advanced cell line development platforms are giving biopharma companies new tools to overcome expression challenges, improve stability and reach the clinic faster.
A new five-year biotech plan has been released by the Chinese government, revealing ambitious goals such as achieving five blockbuster medicines on the global markets in that time.
Electra Therapeutics has exceeded its initial fundraising plans as it becomes the 26th biotech to debut publicly this year and outlines pivotal development plans for its monoclonal antibody ipsoprubart.
As Xenon Pharmaceuticals announced that azetukalner has reached the FDA for focal seizures, the company also disclosed the emergence of psychosis adverse events in psychiatric trials of the drug, triggering a temporary pause.
The market approval for Fayuvi, which was rejected in 2025 due to manufacturing problems, comes shortly after Ultragenyx got the FDA nod for its first gene therapy last month.
Bristol Myers Squibb acquired the degrader-antibody conjugate from Orum Therapeutics in 2023 for $100 million upfront and the possibility of up to $80 million more in milestones.
PRESS RELEASES
Following a horizontal acquisition in December 2025, the companies are realising marked synergies under an ambitious integration program that has successfully aligned manufacturing processes to enable a full dual source supply strategy, which is being launched at CPHI Milan, 6–8 October 2026.
BioMark Announces Participation in upcoming MSACL 2026 and BIOHorizon 2026 Life Sciences Conferences
The Company will provide an update on the clinical translation of its biomarker platform and showcase industry collaborations supporting scalable, high-throughput mass spectrometry.
· New U.S. subsidiary, NovAccel Isotopes Inc., established to support North American growth and long-term global supply ambitions in Ac-225 · Arnaud Lesegretain appointed Director and Chief Commercial and Business Officer of NovAccel, Inc., and CEO of NovAccel Isotopes Inc.; Takashi Mizukami appointed Director and Chief Strategy Officer
The first open guide to make each client a learning loop: clinics measure, intervene and re-measure; the records train biomedical world models; better models return sharper whole-life care