FDA News and Regulatory Updates

The novel therapy combines aztreonam, a monobactam antibiotic, and avibactam, a β-lactamase inhibitor.

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.

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

Todd Bertoch, MD, reviews the significant findings on relief of pain from the 2 pivotal studies and lauds the remarkable safety profile of the novel nonopoid analgesic Journavx.

Journavx is the first and only approved non-opioid oral pain signal inhibitor and the first new class of pain medicine approved in more than 20 years.

A single oral dose of Symbravo provided rapid migraine pain freedom and return to normal functioning within 2 hours, and sustained efficacy through 24 and 48 hours.

The Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test is designed to help identify patients with amyloid pathology associated with AD.

Georgetown University memory disorders expert R Scott Turner, PhD, MD, reviews the science behind approval of lecanemab for monthly maintenance dosing of lecanemab.

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

Once every four weeks maintenance dosing of lecanemab may be easier for patients and care partners to continue treatment.

These test panels allow clinicians to diagnose multiple STIs from a single specimen, with results available in about 20 minutes.

The approval of esketamine follows an FDA Priority Review and is based on data showing that esketamine alone demonstrated rapid and superior improvement in depressive symptoms compared with placebo.

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

Mineralys Therapeutics also expects topline data from its phase 2 study of lorundrostat for the treatment of uncontrolled hypertension or resistant hypertension when used as an add-on therapy.

The agency estimates that limiting nicotine levels could lead to 1.8 million fewer tobacco-related deaths by 2060 and health care savings of $1.1 trillion a year over the next 40 years.

Marketed as Omvoh, the therapy is already approved as a first-in-class treatment for moderately to severely active ulcerative colitis.