The agency combed trials, real-world claims data, and case reports for two years before putting NAION on every GLP-1 label. The absolute risk is tiny, the relative signal is real, and the decision says a lot about how FDA weighs incomplete evidence.
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With its November 28 FDA target date approaching, PolyPid is preparing for a potential launch while pursuing European partnerships and advancing diabetic foot infection candidate PD01B.
Agios won a decisive hemoglobin response in sickle cell but missed the pain-crisis endpoint. A liver-safety question has now pushed the mitapivat decision to February.
Lonza acquires Merck KGaA's five US CDMO plants for antibody-drug conjugates, viral vectors, and lipid nanoparticles, accepting a below-group margin until the 2030s. Merck KGaA exits toll manufacturing and keeps BioReliance.
In depth
Gilead Sciences is paying $1.275 billion upfront for an oral IL-23 receptor drug with no efficacy data, staking a claim on an all-oral IBD franchise built around its own emvistegrast.
Read the storyFDA expanded Anktiva's use to BCG-unresponsive, high-grade papillary-only bladder cancer without a dedicated trial, leaning on earlier carcinoma in situ data and scientific similarities. The move sets a precedent developers of rare indications will study closely.
Viatris is paying $1.65 billion for Pacira, roughly 2.2 times trailing revenue. The price only makes sense if you count EXPAREL's early 2030 licensed generic cliff and the four years of runway before it.
With only about 5% of rare conditions carrying an FDA-approved treatment, the agency is trying to turn case-by-case flexibility into written, predictable defaults. Whether that produces certainty or new rigidity is the open question.
A Nature paper finds that one arginine transfer RNA, tRNA1 Arg(UCU), keeps prostate tumors on androgen receptor signaling. When it falls, cells slip into a lineage-plastic, AR-inhibitor-resistant state.
