A Prescription Drug User Fee Act target date of February 12, 2027 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application ...

HealthDay News — A new executive order calls for American children to be routinely immunized against 11 diseases instead of the 17 now recommended by federal health officials. President Donald Trump ...

FDA acceptance of the new drug application for lonafarnib marks a key milestone toward an oral treatment option for chronic hepatitis D.

The 4C meningococcal B (MenB) vaccine confers modest protection against gonorrhea among adolescents, according to a study published online August 4 in Open Foru ...

Single-dose DT120 ODT achieved significant, sustained reductions in HAM-A anxiety scores vs placebo at week 12, with clinical efficacy observed as early as day 2. Positive topline data were announced ...

Thirteen conditional recommendations developed, including in relation to guiding therapy during exacerbations.

A Prescription Drug User Fee Act target date of March 22, 2027 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License ...

Prespecified primary analyses showed significant improvement over placebo in patients aged 71 and older and those with a baseline 6MWD below 333 meters.

The recalled product is labeled Tyenne (tocilizumab-aazg) Injection 400mg/20mL (20mg/mL)20mL vials; Lot# 16UI07; NDC# 65219-594-20; Expiration Date of 08/2028. One lot of Tyenne ® (tocilizumab-aazg) ...

The table below is a review of notable updates that occurred in July 2026 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

HealthDay News — A multistate outbreak of Salmonella infections has been linked to fresh jalapeño peppers imported from Sinaloa, Mexico, according to federal health officials.

Tudriqev in combination with nivolumab achieved a 24.2% ORR and a median DoR of 14.1 months. The Food and Drug Administration (FDA) has granted accelerated approval to Tudriqev ™ (vusolimogene ...