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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.
FEATURED STORIES
Big Pharma needs more—not fewer—bold bets on rare and difficult diseases after Novartis’ efforts to invest in muscular dystrophy and ALS hit major roadblocks this month.
BioSpace takes stock of the psychedelic therapeutics space, which is once again on the cusp of its first FDA approval.
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
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Read our takes on the biggest stories happening in the industry.
Newly solidified in their roles as the heads of CBER and CDER, Karim Mikhail and Michael Davis have been working for months to right the ship that had begun to capsize under former Commissioner Marty Makary. Meanwhile, Jared Seehafer will become the first-ever deputy commissioner focused on artificial intelligence.
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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.
The multi-drug partnership with Orbis Medicines—which Novo Holdings has backed since the biotech’s seed rounds—is focused on cardiometabolic targets, but the technology at the center of the deal could deliver oral weight loss candidates. Obesity rival Eli Lilly has also helped fund Orbis.
While increases in the interest rate from the Federal Reserve are usually bad for biotech, the sector at this moment is poised to withstand the blow, according to analysts, though earlier stage companies may be left in the lurch.
Novartis stands alongside Big Pharma peers that have similarly invested in technologies to penetrate the blood-brain barrier, including GSK, Roche and Eli Lilly.
With just over $10 million in cash available to fuel operations through the end of the year, Longeveron is undertaking a strategic review after the failure of a cardiovascular study.
The partners will focus R&D efforts on immunological and inflammatory conditions using Dualitas’ DualScreen Bispecific Discovery Engine platform.
In this episode of Denatured, you’ll hear Philip Jacob Rosenfeld, professor of Ophthalmology at the University of Miami Health System and Bascom Palmer Eye Institute, and Wesley Jackson, chief science officer at Valitor. We talk about the eye condition call wet age-related macular degeneration (AMD), the limits of anti‑VEGF therapy and the push for true durability to change a patient’s life.