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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
Despite the late-stage fail, Vistagen will nevertheless continue to push its drug candidate forward and meet with the FDA to align on a potential registrational path.
Sarepta Therapeutics is seeking to convert the accelerated approval of its therapeutic exon-skippers for Duchenne muscular dystrophy to full despite the drugs’ failure to improve motor function in a confirmatory trial.
The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.
Innovation drives CROs to win new business, but unchecked customization creates complexity that undermines reproducibility, weakens renewals and leads to turnover—making standardization a strategic necessity, not a constraint.
The U.K.’s core biotech cluster continues to produce world‑class science, but investors say limited talent mobility, uneven regional growth and tightening early‑ and mid‑stage capital are slowing the country’s ability to scale new companies.
The 2022 search approach is no longer working. Companies need to think critically about how they are acquiring top regulatory, clinical and commercial executives or risk their programs in this new regulatory and market reality.
The total of 52 mergers and acquisitions for the first half of 2026 reflects what analysts, industry watchers and executives are saying over and over: M&A is back.
Who is the highest paid CEO in all of pharma? In this special edition, BioSpace examines top paid CEOs and their pay packages.
Unicycive Therapeutics and Sobi received complete response letters for kidney disease and gout filings, respectively, after the FDA found fault with their manufacturing partners.
At the BIO International Convention in San Diego, attendees marked the 50th anniversary of original biotech Genentech, reflecting on the immense challenges facing companies as China becomes a powerhouse innovator.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
Vijay Kumar, acting director of CBER’s Office of Therapeutic Products, will leave his role at a tumultuous time for the FDA.
PRESS RELEASES
• Augurex’s SPINEstat® (Anti-14-3-3eta Multiplex for axial spondyloarthritis) test has been selected as a finalist in the ADLM 2026 Disruptive Technology Award, one of laboratory medicine’s most competitive recognition programs. • Augurex will present at ADLM 2026 on July 27 in Anaheim, CA, with a dedicated finalist kiosk on the Expo Floor July 28–30. • The recognition underscores Augurex’s leadership in developing biomarker-driven diagnostics that address critical unmet needs across autoimmune and inflammatory diseases.
