Drugs

Lilly Gets Orphan Status for Pancreatic Cancer Drug

FDA has granted Eli Lilly an orphan drug designation for olomorasib as a monotherapy for treating adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation, as determined by an FDA-approved test. Olomorasib is described as an investigational, potent and highly selective next-generation inhibitor of KRAS G12C, and was previously granted a breakthrough therapy designation, in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab), for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation and PD-L1 expression greater than 50%, as determined by FDA-approved tests.

Sharfstein et al. Urge Stronger FDA Oversight of Accelerated Approvals

FDA should strengthen its oversight and enforcement of confirmatory trials for accelerated approval drugs, with Medicare and Medicaid payments limited until the products’ clinical benefits are confirmed, according to a new proposal for expanding the agency's role in addressing drug costs. The proposal is one of several recommendations

FDA Actions Signal Scrutiny of Telehealth Prescribing Models: Attorneys

Recent FDA enforcement activities could signal increased scrutiny of telehealth platforms that facilitate prescribing of compounded drugs, particularly when technology or standardized processes may undermine individualized clinical decision-making, according to attorneys at ArentFox Schiff. In an 10/5 Insights post, attorneys Abha Kundi and Matthew Berlin noted FDA'

AI Model Detects Pancreatic Cancer Before Visible on CT Scans

An artificial intelligence (AI) model detected pancreatic cancer on routine CT scans more than a year before clinical diagnosis and substantially outperformed expert radiologists in identifying early cancers that were not yet visually apparent, according to a study published in BMJ’s Gut. Researchers led by Mayo Clinic developed a

TikTok Misinformation on Acetaminophen, Autism Surged After FDA Notice

Misinformation on TikTok linking acetaminophen use during pregnancy with autism surged following a 9/2025 FDA announcement (see story) on the issue, with misleading videos attracting disproportionate attention, according to research presented at the American Academy of Pediatrics' 2026 National Conference & Exhibition. Researchers analyzed 53 TikTok videos posted

Read more

Sharfstein et al. Urge Stronger FDA Oversight of Accelerated Approvals

FDA Actions Signal Scrutiny of Telehealth Prescribing Models: Attorneys

AI Model Detects Pancreatic Cancer Before Visible on CT Scans

TikTok Misinformation on Acetaminophen, Autism Surged After FDA Notice