FDA News

The FDA has set the Prescription Drug User Fee Act target action date for bronchiectasis for August 12, 2025, Insmed Incorporated announced.

Onapgo is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in people with advanced Parkinson disease.

Hardware or software changes as well as user adjustments may disable or mute alerts for elevated glycemia, medication use, and other diabetes management essentials, the agency said.

Your daily dose of the clinical news you may have missed.

The Tina-quant® Lipoprotein (a) Gen.2 Molarity assay measures Lp(a) in molar units, providing a more accurate particle-based risk assessment than mass units.

Your daily dose of the clinical news you may have missed.

Tepper, principal investigator for phase 3 trials of Symbravo as acute treatment for migraine in adults, reviews the new drug's dual MOA and target patient populations.

An oral antibiotic for drug-resistant UTIs, a long-awaited therapy for congenital adrenal hyperplasia, and more.

The pivotal INTERCEPT and MOMENTUM phase 3 clinical trials served as foundational evidence for the efficacy of the combination therapy across migraine presentations.

Mariano, a well-known researcher in regional anesthesiology and acute pain medicine, talks about the Journavx difference, including the drug's safety profile.