FDA

Yesterday Applied Therapeutics announced that the FDA is extending the review period for its investigational aldose reductase inhibitor govorestat for the treatment of classic galactosemia. The biotech now expects a verdict by Nov. 28, 2024.

Gilead Sciences’ Vemlidy on Thursday secured a label expansion from the FDA, allowing the antiviral drug’s use to treat chronic hepatitis B in pediatric patients aged six years and older.

The German company reported in February that it expects to grow an average of 10% per year. Nearly half of that is anticipated to come from its association with drugs in the GLP-1 class.

Bristol Myers Squibb

BMS said its experimental drug to treat Crohn’s disease, a chronic inflammatory bowel condition, did not help patients achieve disease remission in a late-stage study.

Analyzing social media using artificial intelligence may pick up signals of depression in white Americans but not in Black counterparts, according to a study that highlights the risk of training AI models for healthcare-related tasks without data from diverse racial and ethnic groups.

The U.S. Centers for Disease Control and Prevention has issued an advisory alerting healthcare providers about an increase in invasive meningococcal disease and urging them to ensure necessary vaccinations against the deadly disease.

FDA

After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.

According to its SEC filing at the time, Boundless will use the IPO proceeds to fund the development of its extrachromosomal DNA (ecDNA) programs, being developed for cancer indications.

Citing a JAMA study that found Ozempic could be profitably produced at under $5 per month, Senator Bernie Sanders on Wednesday called on Novo Nordisk to lower prices for the diabetes treatment and the weight-loss drug Wegovy.

This transaction is the latest to highlight Big Pharma’s growing interest in developing novel targets for inflammation and immunology (I&I) treatments, as well as the potential for cutting-edge computational drug development.