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Articles
Obstructive Sleep Apnea and Hypertension Update: FDA Clears Phase 2 Trial of Lorundrostat, an Oral Aldosterone Synthase Inhibitor
January 17, 2025
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
January 16, 2025
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
January 15, 2025
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
January 15, 2025
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
January 14, 2025
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
January 13, 2025
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
January 13, 2025
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
January 13, 2025
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
January 08, 2025
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
January 02, 2025
NX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA.