Following a successful appeal of a December 2025 CRL, the FDA concluded that Outlook Therapeutics' existing data provided substantial evidence, eliminating the need for new clinical trials.

Metastatic androgen pathway modulation-naïve or -sensitive prostate cancer was previously referred to as metastatic hormone-sensitive prostate cancer.

Credit: Bayer. Two phase 3 trials supported the approval of gadoquatrane, a novel macrocyclic GBCA for imaging CNS and non-CNS pathologies. The novel macrocyclic contrast agent delivers high-quality ...

Results showed ozekibart significantly reduced the risk of disease progression or death by 52% compared with placebo. The Food and Drug Administration (FDA) has accepted for review the Biologics ...

A voluntary recall has been issued for a lot of Beekeeper’s Naturals Saline Nasal Spray following the detection of Aspergillus mold.

Three studies show benefits in adults inadequately controlled with diet and exercise, receiving metformin, using basal insulin ...

Mesothelioma deaths and diagnoses continue to rise in the United States despite regulation limiting the use of asbestos, according to a study published online June 11 in JCO Global Oncology. Kyle ...

The phase 3 trial is evaluating the long-term effects of sibeprenlimab-szsi on kidney function in adults with primary immunoglobulin A nephropathy.

Findings showed navacaprant did not significantly improve MADRS total scores compared with placebo in either KOASTAL-2 (P =.813) or KOASTAL-3 (P =.480). Topline data were announced from two phase 3 ...

Children may experience shorter sensor wear times due to physical and behavioral differences. The Food and Drug Administration (FDA) has cleared Dexcom’s Stelo Glucose Biosensor System for children ...

The over-the-counter softgels are used to relieve pressure, bloating, and fullness by rapidly breaking up gas bubbles in the ...

A wearable ultrasound patch can provide continuous, real-time information about blood flow in the fetus and umbilical cord, according to a study published online May 26 in Nature Biotechnology. Geonho ...