The Pharmaceutical KnowledgeBase (PharmaKB.com) provides research and financial intelligence about companies and their approved drugs as well as drug candidates in clinical trials. In this quarterly PharmaKB report, we provide an update about novel drugs approved by the US FDA in of this year. By referencing new drugs as “novel” the FDA is confirming that the medicine being approved contains ingredients and/or a mechanism of action that the FDA hasn’t previously approved.
2024 | April | May | June
April 2024 – Novel FDA Drug Approvals
Ceftobiprole medocaril
News Release: https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses
Pegulicianine
- Drug: Pegulicianine
- Trade name: Lumisight
- Therapeutic Area: Breast cancer imaging MeSH D001943
- Manufacturer: Lumicell
- FDA Approval Date: April 17, 2024
- Classification: Fluorescent imaging
- Drug Class: Malignancy photosensitizers
- Clinical Trials: https://www.app.pharmakb.com/drug-report/pegulicianine#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/pegulicianine#safety
- Description: Pegulicianine, sold under the brand name Lumisight, is an optical imaging agent indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. It is administered by intravenous injection.
News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214511s000lbl.pdf
Nogapendekin alfa
News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761336s000lbl.pdf
Tovorafenib
News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218033s000lbl.pdf
Mavorixafor
- Drug: Mavorixafor
- Trade name: Xolremdi
- Therapeutic Area: WHIM syndrome MeSH C536697
- Manufacturer: X4 Pharmaceuticals
- FDA Approval Date: April 26, 2024
- Classification: Small molecule
- Drug Class: CXCR receptor antagonists
- Clinical Trials: https://www.app.pharmakb.com/drug-report/mavorixafor#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/mavorixafor#safety
- Description: Mavorixafor, sold under the brand name Xolremdi, is a CXC chemokine receptor 4 antagonist indicated in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes. It is administered orally.
News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218709s000lbl.pdf
May 2024 – Novel FDA Drug Approvals
Tarlatamab-dlle
News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761344s000lbl.pdf
June 2024 – Novel FDA Drug Approvals
Imetelstat
News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217779s000lbl.pdf
Elafibranor
- Drug: Elafibranor
- Trade name: Iqirvo
- Therapeutic Area: Biliary cholangitis MeSH D008105
- Manufacturer: GENFIT
- FDA Approval Date: June 10, 2024
- Classification: Small molecule
- Drug Class: PPAR agonist
- Clinical Trials: https://www.app.pharmakb.com/drug-report/elafibranor#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/elafibranor#safety
- Description: Elafibranor, sold under the brand name Iqirvo, is a peroxisome proliferator-activated receptor (PPAR) agonist indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. It is administered orally.
News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218860s000lbl.pdf
Sofpironium
News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217347s000lbl.pdf
Crovalimab-akkz
- Drug: Crovalimab-akkz
- Trade name: Piasky
- Therapeutic Area: Paroxysmal nocturnal hemoglobinuria MeSH D006457
- Manufacturer: Genentech
- FDA Approval Date: June 20, 2024
- Classification: Antibody
- Drug Class: Monoclonal antibodies
- Clinical Trials: https://www.app.pharmakb.com/drug-report/crovalimab#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/crovalimab#safety
- Description: Crovalimab-akkz, sold under the brand name Piasky, is a complement C5 inhibitor indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria. It is administered by a loading dose administered by intravenous infusion, followed by subcutaneous injection.
News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761388s000lbl.pdf
Ensifentrine
News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217389s000lbl.pdf