STAT+: How a four-month FDA delay forced a small biotech company to close its doors
In February, a small biotech company reached a breakthrough with the FDA, agreeing to a clinical trial plan. The problem: The agreement came four months too late.
In February, a small biotech company reached a breakthrough with the FDA, agreeing to a clinical trial plan. The problem: The agreement came four months too late.
“There is no off switch when the crisis is your child,” writes Liz Koch.
Scientists have identified a little-known receptor, GPR133, as a powerful regulator of bone strength. By activating it with a newly discovered compound called AP503, they were able to boost bone density in mice and counteract osteoporosis-like damage. The finding opens the door to a new kind of treatment that could not only prevent bone loss but also rebuild weakened bones, offering fresh hope for
Eli Lilly has published a video about how medicines affect lives to mark its 150th anniversary and the arrival of college basketball stars in its home city.
VML Health has published a report about 10 trends defining the future of healthcare, making the case that pharma marketers must adapt to patients shifting their goals from lifespan to “joyspan.”
Scientists have identified a potential new weapon against hepatitis E, a virus with no approved treatment and tens of thousands of deaths each year. The drug bemnifosbuvir, currently in trials for hepatitis C, was found to block the virus from replicating by disrupting its genetic machinery. Tests in cells and animals showed strong effectiveness without harming healthy tissue. If ongoing trials su
Scientists in Canada have uncovered a surprising weakness in glioblastoma, one of the deadliest brain cancers. They found that certain brain cells—once believed to only support healthy nerves—can actually help tumors grow by sending signals that strengthen cancer cells. When researchers blocked this communication, tumor growth slowed dramatically in lab models.
Scientists have uncovered a powerful new clue in the mystery of brain aging: a single protein called FTL1. In aging mice, higher levels of this protein weakened connections between brain cells and led to memory decline. But when researchers reduced FTL1, something remarkable happened — the brain began to recover, rebuilding lost connections and restoring memory performance.
Scientists have created an artificial saliva using a sugarcane protein that can protect teeth and fight bacteria. The key ingredient, CANECPI-5, binds directly to enamel, forming a shield against acids that cause decay. Early tests show it works even better when paired with fluoride and xylitol, significantly reducing damage to teeth. The innovation could be especially life-changing for cancer pat
A new study reveals that gut bacteria and metabolites may hold the key to detecting serious digestive diseases earlier and more easily. Using AI, scientists found that biomarkers linked to one condition can often predict others, showing these diseases are more interconnected than previously thought. This cross-disease insight could lead to faster diagnoses without invasive procedures.
In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.