• Tepylute (Shorla)
    • To treat breast and ovarian cancer
  • Ohtuvayre (Verona Pharma)
    • For the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients
  • Vyvgart Hytrulo (Argenx)
    • For the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
  • PiaSky (Genentech)
    • For the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.
  • Wakix (Harmony Biosciences)Expanded Indication
    • For the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy.
  • Krazati (Mirati Therapeutics)
    • With cetuximab for certain patients with KRAS G12C–mutated colorectal cancer (CRC).
  • Sofdra (Botanix Pharmaceuticals)
    • To treat primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years and older.
  • Elevidys (Sarepta Therapeutics)Expanded Indication
    • Expansion of label to include treatment of individuals with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who are at least 4 years of age.
  • Skyrizi (AbbVie)New Indication
    • For adults with moderately to severely active ulcerative colitis.
  • Vigafyde (Pyros Pharmaceuticals)
    • For the treatment of pediatric patients 1 month to 2 years of age with infantile spasms (IS), where the potential benefits outweigh the potential risk of vision loss.
  • Capvaxive (Merck)Expanded Indication
    • For Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults.
  • Yimmugo (Grifols)Expanded Indication
    • To treat primary immunodeficiencies (PID).
  • Keytruda (Merck)New Indication
    • In combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
  • Imfinzi (AstraZeneca)Expanded Indication
    • For Mismatch Repair Deficient Primary Advanced or Recurrent Endometrial Cancer.
  • Blincyto (Amgen)Expanded Indication
    • In CD19-Positive Philadelphia Chromosome-Negative B-ALL in the Consolidation Phase.
  • Emflaza (Cranbury Pharmaceuticals)Now Generic
    • To treat DMD in patients 5 years of age and older.
  • Augtyro (Bristol Myers Squibb)New Indication
    • In patients 12 years and older who have solid tumors that have an NTRK gene fusion.
  • Farxiga (AstraZeneca)Expanded Indication
    • To improve glycaemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older.
  • Xigduo XR (AstraZeneca)Expanded Indication
    • To improve glycaemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older.
  • Kevzara (Sanofi / Regeneron)New Indication
    • For the treatment of patients weighing 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA).
  • Iqirvo (Ipsen)
    • In combination with ursodeoxycholic acid (UDCA) in adults who do not respond adequately to UDCA or as monotherapy in patients unable to tolerate UDCA.
  • Klisyri XR (Almirall)Expanded Indication
    • For actinic keratosis (AK) of the face or scalp.
  • Motpoly XR (Aucta Pharmaceuticals)New Indication
    • For Primary Generalized Tonic-Clonic Seizures (Adjunctive Treatment).
  • Arexvy (GlaxoSmithKline)Expanded Indication
    • For the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk.
  • Rytelo (Geron Corporation)
    • For the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).
  • Rinvoq (Abbvie)Expanded Indication
    • For patients aged 2 years or older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) who cannot tolerate or achieve adequate disease response with one or more tumor necrosis factor (TNF) blockers.

Sign up for alerts and stay informed on the latest published guidelines, FDA decisions, and more!

Copyright © 2024 Guideline Central, All Rights Reserved.