Obstructive Sleep Apnea and Hypertension Update: FDA Clears Phase 2 Trial of Lorundrostat, an Oral Aldosterone Synthase Inhibitor
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.
FDA Approves Lilly’s Mirikizumab-mrkz for Crohn’s Disease
Marketed as Omvoh, the therapy is already approved as a first-in-class treatment for moderately to severely active ulcerative colitis.
Atopic Dermatitis pipeline: IND Application Cleared by FDA for Novel Monoclonal Antibody OX40 Antagonist
Early proof-of-concept phase 1a data from the trial is anticipated in the third quarter of 2025.
Elinzanetant VMS update: As Positive Results Pile Up, Bayer Readies for Menopause Treatment’s Future
FDA action date set for July 26, 2025.
Neffy Update: FDA to Review 1 mg Version in First Quarter 2025, for Young Children with Type 1 Allergic Reactions
If approved, neffy 1 mg will be the only needle-free epinephrine treatment available for the younger, school-aged population.
FDA Reviewing New Prefilled Syringe Formulation for GSK’s Shingrix
An FDA decision on GSK's Shingrix application is expected by June 20, 2025.
Lumateperone for MDD Update: J&J Acquires Intra-Cellular as FDA sNDA Decision Approaches
The acquisition brings lumateperone, known as Caplyta, and the clinical-stage agent ITI-1284, for generalized anxiety disorder and Alzheimer's agitation, into the J&J fold.
Mediar Therapeutics and Lilly Enter Global Licensing Agreement for WISP1 Antibody in Idiopathic Pulmonary Fibrosis
The planned Phase 2 trial in IPF will focus on assessing MTX-463’s safety, pharmacokinetics, and efficacy.
FDA Grants Fast Track Designation to Posdinemab for Early Alzheimer's Disease
Johnson & Johnson's posdinemab aims to slow tau pathology in early and preclinical Alzheimer’s disease populations.
FDA Assigns PDUFA Date for TNX-102 SL, a Nonopioid Analgesic for Fibromyalgia
NX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA.
Delix Therapeutics Announces Results from Phase 1 Trial of DLX-001 for Major Depressive Disorder
A phase 1b and Phase 2 study are up next for the novel potential MDD treatment.
New Data on Needle Free Epinephrine Spray Presented at ACAAI 2024
A summary of new data presented at the 2024 American College of Allergy, Asthma & Immunology Annual Scientific Meeting.
Caffeine to the Extreme: A High-octane Quiz
The caffeine in an average cup o' joe delivers the ideal morning jolt, but concentrated amounts can be fatal. How little is dangerous? Find out, here.
Test Your HCV IQ: 5 Quick Questions
When to test, how long to treat, what adjustments to make to avoid dangerous drug interactions; test your HCV IQ with a short quiz on a range of topics.
10 Cannabis Questions for Primary Care
Are you up-to-date on the wide variety and variable potency of cannabis products your patients may use? Test yourself and find out.
10 Devices that Could Pose Problems for Patients with ICDs
Modern ICDs have built-in protection from interference by most current technologies. But do you know which ones could be problematic for your patients?
5-Question Quiz on HCV
It's a short quiz but it covers a broad range of knowledge about testing, treatment, and drug choices in persons with HCV infection.
