FDA
Through its AI Consortium and global forums, DIA is translating high‑level AI guidance into concrete workflows that match oversight to risk, from low‑stakes automation to decision‑critical regulatory analyses.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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Boehringer Ingelheim on Wednesday won the FDA’s approval for a high-concentration and citrate-free version of its Humira biosimilar Cyltezo, targeting AbbVie’s blockbuster drug.
J&J and BMS’ challenges to Medicare drug price negotiations shut down in federal court less than a week after BMS announced it was laying off more than 2,000 employees.
Neurocrine Biosciences on Tuesday won the FDA’s approval for a sprinkle capsule formulation of Ingrezza, providing a more convenient route of treatment for Huntington’s disease patients with trouble swallowing.
Based on strong overall and progression-free survival data in its Phase III confirmatory study, Pfizer and Genmab’s antibody-drug conjugate Tivdak on Monday secured the FDA’s full approval for recurrent or metastatic cervical cancer that had progressed on or after chemotherapy.
After laying off staff in 2022 to extend its cash runway, X4 Pharmaceuticals got its drug for the ultra-rare immunodeficiency disease across the finish line on Monday.
Pfizer will go toe-to-toe with CSL Behring following the FDA’s Friday approval of its hemophilia B gene therapy Beqvez and will launch a warranty program based on the durability of response.
The regulator on Wednesday gave its approval for a new oral antibiotic to treat uncomplicated urinary tract infections in women. UTILITY therapeutics expects to launch Pivya in the U.S. in 2025.
The FDA on Tuesday approved Day One Biopharmaceuticals’ type II RAF inhibitor Ojemda, which is designed to penetrate the blood-brain barrier, for the treatment of relapsed or refractory pediatric low-grade glioma.
The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.
Bouncing back from a previous rejection, ImmunityBio on Monday secured the FDA’s green light for its IL-15 superagonist Anktiva for non-muscle invasive bladder cancer.