--- title: Novel FDA Drug Approvals - 2nd Quarter of 2024 - PharmaKB Report description: Novel FDA drug approvals in Q2 of 2024, including new treatments for molluscum contagiosum, hypertension, and more. Insights from PharmaKB's report. image: https://www.pharmakb.com/hubfs/FDA%20Approved%20PharmaKB%20Report%20Logo-2.png --- # Novel FDA Drug Approvals - 2nd Quarter of 2024 - PharmaKB Report Oct 1, 2024 10:57:10 AM [![Share on facebook](https://7528309.fs1.hubspotusercontent-na1.net/hub/7528309/hubfs/raw_assets/public/mV0_d-web-default-modules_hubspot/img/facebook-color.png?width=24&name=facebook-color.png) ](https://www.facebook.com/share.php?u=https%3A%2F%2Fwww.pharmakb.com%2Fblog%2Fnovel-fda-drug-approvals-pharmakb-report-2024q2%3Futm_medium%3Dsocial%26utm_source%3Dfacebook) [![Share on linkedin](https://7528302.fs1.hubspotusercontent-na1.net/hub/7528302/hubfs/raw_assets/public/mV0_d-web-default-modules_hubspot/img/linkedin-color.png?width=24&name=linkedin-color.png) ](https://www.linkedin.com/shareArticle?mini=true&url=https%3A%2F%2Fwww.pharmakb.com%2Fblog%2Fnovel-fda-drug-approvals-pharmakb-report-2024q2%3Futm_medium%3Dsocial%26utm_source%3Dlinkedin) [![Share on twitter](https://7528304.fs1.hubspotusercontent-na1.net/hub/7528304/hubfs/raw_assets/public/mV0_d-web-default-modules_hubspot/img/twitter-color.png?width=24&name=twitter-color.png) ](https://twitter.com/intent/tweet?original_referer=https%3A%2F%2Fwww.pharmakb.com%2Fblog%2Fnovel-fda-drug-approvals-pharmakb-report-2024q2%3Futm_medium%3Dsocial%26utm_source%3Dtwitter&url=https%3A%2F%2Fwww.pharmakb.com%2Fblog%2Fnovel-fda-drug-approvals-pharmakb-report-2024q2%3Futm_medium%3Dsocial%26utm_source%3Dtwitter&source=tweetbutton&text=) [![Share on email](https://7528311.fs1.hubspotusercontent-na1.net/hub/7528311/hubfs/raw_assets/public/mV0_d-web-default-modules_hubspot/img/email-color.png?width=24&name=email-color.png) ](mailto:?subject=Check+out+https%3A%2F%2Fwww.pharmakb.com%2Fblog%2Fnovel-fda-drug-approvals-pharmakb-report-2024q2%3Futm_medium%3Dsocial%26utm_source%3Demail&body=Check+out+https%3A%2F%2Fwww.pharmakb.com%2Fblog%2Fnovel-fda-drug-approvals-pharmakb-report-2024q2%3Futm_medium%3Dsocial%26utm_source%3Demail)   The Pharmaceutical KnowledgeBase ([PharmaKB.com](https://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](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2024q2#a1) | [May](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2024q2#a2) | [June](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2024q2#a3) **April 2024 – Novel FDA Drug Approvals** **Ceftobiprole medocaril** - **Drug**: [Ceftobiprole medocaril](https://www.pharmakb.com/drug-report/ceftobiprole) - **Trade name**: Zevtera - **Therapeutic Area**: Bloodstream infections and community-acquired bacterial pneumonia MeSH [D018805](https://meshb.nlm.nih.gov/record/ui?ui=D018805); [D011014](https://meshb.nlm.nih.gov/record/ui?ui=D011014); [D018461   ](https://meshb.nlm.nih.gov/record/ui?ui=D018461)  - **Manufacturer**: AVIR Pharma - **FDA Approval Date**: April 3, 2024 - **Classification**: Small Molecule - **Drug Class**: Cephalosporins - **Clinical Trials**:   [https://www.app.pharmakb.com/drug-report/ceftobiprole#clinical](https://www.app.pharmakb.com/drug-report/ceftobiprole#clinical)  - **Adverse Events**:**  **[https://www.app.pharmakb.com/drug-report/ceftobiprole#safety](https://www.app.pharmakb.com/drug-report/ceftobiprole#safety)  - **Description**: Ceftobiprole, sold under the brand name Zevtera, is used to treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia. It is administered by intravenous injection. **News Release**: [https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses](https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses)  **Pegulicianine** - **Drug**: [Pegulicianine](https://www.pharmakb.com/drug-report/pegulicianine) - **Trade name**: Lumisight - **Therapeutic Area**: Breast cancer imaging MeSH [D001943](https://meshb.nlm.nih.gov/record/ui?ui=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](https://www.app.pharmakb.com/drug-report/pegulicianine#clinical)  - **Adverse Events**:**  **[https://www.app.pharmakb.com/drug-report/pegulicianine#safety](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](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214511s000lbl.pdf)  **Nogapendekin alfa** - **Drug**: [Nogapendekin alfa](https://www.pharmakb.com/drug-report/nogapendekin20alfa) - **Trade name**: Anktiva - **Therapeutic Area**: Bladder cancer MeSH [D001749](https://meshb.nlm.nih.gov/record/ui?ui=D001749)  - **Manufacturer**: ImmunityBio - **FDA Approval Date**: April 22, 2024 - **Classification**: Protein - **Drug Class**: Interleukins - **Clinical Trials**:     [https://www.app.pharmakb.com/drug-report/nogapendekin20alfa#clinical](https://www.app.pharmakb.com/drug-report/nogapendekin20alfa#clinical)  - **Adverse Events**:**  **[https://www.app.pharmakb.com/drug-report/nogapendekin20alfa#safety](https://www.app.pharmakb.com/drug-report/nogapendekin20alfa#safety)  - **Description**: Nogapendekin alfa, sold under the brand name Anktiva, is for the treatment of adult patients with BCG unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors. It is administered intravesically with BCG. **News Release**: [https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761336s000lbl.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761336s000lbl.pdf)  **Tovorafenib** - **Drug**: [Tovorafenib](https://www.pharmakb.com/drug-report/tovorafenib) - **Trade name**: Ojemda - **Therapeutic Area**: Pediatric low-grade glioma MeSH [D005910](https://meshb.nlm.nih.gov/record/ui?ui=D005910)  - **Manufacturer**: Day One Biopharmaceuticals - **FDA Approval Date**: April 23, 2024 - **Classification**: Small molecule - **Drug Class**: Kinase inhibitor - **Clinical Trials**:    [https://www.app.pharmakb.com/drug-report/tovorafenib#clinical](https://www.app.pharmakb.com/drug-report/tovorafenib#clinical)  - **Adverse Events**:**  **[https://www.app.pharmakb.com/drug-report/tovorafenib#safety](https://www.app.pharmakb.com/drug-report/tovorafenib#safety)  - **Description**: Tovorafenib, sold under the brand name Ojemda, is approved under accelerated approval for treatment of  relapsed or refractory pediatric low-grade glioma. It is administered orally. **News Release**: [https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218033s000lbl.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218033s000lbl.pdf)   **Mavorixafor** - **Drug**: [Mavorixafor](https://www.pharmakb.com/drug-report/mavorixafor) - **Trade name**: Xolremdi - **Therapeutic Area**: WHIM syndrome MeSH [C536697](https://meshb.nlm.nih.gov/record/ui?ui=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](https://www.app.pharmakb.com/drug-report/mavorixafor#clinical)  - **Adverse Events**:**  **[https://www.app.pharmakb.com/drug-report/mavorixafor#safety](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](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218709s000lbl.pdf)  **May 2024 – Novel FDA Drug Approvals** **Tarlatamab-dlle** - **Drug**: [Tarlatamab-dlle](https://www.pharmakb.com/drug-report/tarlatamab-dlle) - **Trade name**: Imdelltra - **Therapeutic Area**: Small cell lung cancer MeSH [D055752](https://meshb.nlm.nih.gov/record/ui?ui=D055752)  - **Manufacturer**: Amgen - **FDA Approval Date**: May 16, 2024 - **Classification**: Small molecule - **Drug Class**: Bispecific T cell engager - **Clinical Trials**:   [https://www.app.pharmakb.com/drug-report/tarlatamab-dlle#clinical](https://www.app.pharmakb.com/drug-report/tarlatamab-dlle#clinical)  - **Adverse Events**:**  **[https://www.app.pharmakb.com/drug-report/tarlatamab-dlle#safety](https://www.app.pharmakb.com/drug-report/tarlatamab-dlle#safety)  - **Description**: Tarlatamab-dlle, sold under the brand name Imdelltra, is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T cell engager indicated for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. It is administered by intravenous infusion. **News Release**: [https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761344s000lbl.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761344s000lbl.pdf)  **June 2024 – Novel FDA Drug Approvals** **Imetelstat** - **Drug**: [Imetelstat](https://www.pharmakb.com/drug-report/imetelstat) - **Trade name**: Rytelo - **Therapeutic Area**: Myelodysplastic syndromes MeSH [D009190](https://meshb.nlm.nih.gov/record/ui?ui=D009190)  - **Manufacturer**: Geron - **FDA Approval Date**: June 6, 2024 - **Classification**: Oligonucleotide - **Drug Class**:  Enzyme inhibitors: telomerase inhibitors - **Clinical Trials**:     [https://www.app.pharmakb.com/drug-report/imetelstat#clinical](https://www.app.pharmakb.com/drug-report/imetelstat#clinical)  - **Adverse Events**:**  **[https://www.app.pharmakb.com/drug-report/imetelstat#safety](https://www.app.pharmakb.com/drug-report/imetelstat#safety)  - **Description**: Imetelstat, sold under the brand name Rytelo, is used to treat low- to intermediate-1 risk myelodysplastic syndromes. It is administered by intravenous infusion. **News Release**: [https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217779s000lbl.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217779s000lbl.pdf)  **Elafibranor** - **Drug**: [Elafibranor](https://www.pharmakb.com/drug-report/elafibranor) - **Trade name**: Iqirvo - **Therapeutic Area**: Biliary cholangitis MeSH [D008105](https://meshb.nlm.nih.gov/record/ui?ui=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](https://www.app.pharmakb.com/drug-report/elafibranor#clinical)  - **Adverse Events**:**  **[https://www.app.pharmakb.com/drug-report/elafibranor#safety](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](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218860s000lbl.pdf)  **Sofpironium** - **Drug**: [Sofpironium](https://www.pharmakb.com/drug-report/sofpironium20bromide) - **Trade name**: Sofdra - **Therapeutic Area**: Primary axillary hyperhidrosis MeSH [D006945](https://meshb.nlm.nih.gov/record/ui?ui=D006945)  - **Manufacturer**: Botanix Pharmaceuticals - **FDA Approval Date**: June 18, 2024 - **Classification**: Small molecule - **Drug Class**: Quaternary ammonium derivatives; quaternary ammonium derivatives - **Clinical Trials**:   [https://www.app.pharmakb.com/drug-report/sofpironium#clinical](https://www.app.pharmakb.com/drug-report/sofpironium#clinical)  - **Adverse Events**:**  **[https://www.app.pharmakb.com/drug-report/sofpironium#safety](https://www.app.pharmakb.com/drug-report/sofpironium#safety)  - **Description**: Sofpironium, sold under the brand name Sofdra, is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. It is administered by topical use. **News Release**: [https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217347s000lbl.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217347s000lbl.pdf)  **Crovalimab-akkz** - **Drug**: [Crovalimab-akkz](https://www.pharmakb.com/drug-report/crovalimab) - **Trade name**: Piasky - **Therapeutic Area**: Paroxysmal nocturnal hemoglobinuria MeSH [D006457](https://meshb.nlm.nih.gov/record/ui?ui=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](https://www.app.pharmakb.com/drug-report/crovalimab#clinical)  - **Adverse Events**:**  **[https://www.app.pharmakb.com/drug-report/crovalimab#safety](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](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761388s000lbl.pdf)  **Ensifentrine** - **Drug**: [Ensifentrine](https://www.pharmakb.com/drug-report/ensifentrine) - **Trade name**: Ohtuvayre - **Therapeutic Area**: Chronic obstructive pulmonary disease MeSH [D029424](https://meshb.nlm.nih.gov/record/ui?ui=D029424)  - **Manufacturer**: Verona Pharma - **FDA Approval Date**: June 26, 2024 - **Classification**: Small molecule - **Drug Class**: Phosphodiesterase inhibitor - **Clinical Trials**:    [https://www.app.pharmakb.com/drug-report/ensifentrine#clinical](https://www.app.pharmakb.com/drug-report/ensifentrine#clinical)  - **Adverse Events**:**  **[https://www.app.pharmakb.com/drug-report/ ensifentrine#safety](https://www.app.pharmakb.com/drug-report/%20ensifentrine#safety)  - **Description**: Ensifentrine, sold under the brand name Ohtuvayre, is a phosphodiesterase 3 (PDE3) inhibitor and phosphodiesterase 4 (PDE4) inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. It is administered through oral inhalation. **News Release**: [https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217389s000lbl.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217389s000lbl.pdf)  [PharmaKB Reports](https://www.pharmakb.com/blog/tag/pharmakb-reports) ## Read On [![](https://www.pharmakb.com/hs-fs/hubfs/FDA%20Approved%20PharmaKB%20Report%20Logo-2.png?width=352&name=FDA%20Approved%20PharmaKB%20Report%20Logo-2.png) ](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2023q2) ### [Novel FDA Drug Approvals - 2nd Quarter of 2023 - PharmaKB Report](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2023q2) [![](https://www.pharmakb.com/hs-fs/hubfs/FDA%20Approved%20PharmaKB%20Report%20Logo-2.png?width=352&name=FDA%20Approved%20PharmaKB%20Report%20Logo-2.png) ](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2024q1) ### [Novel FDA Drug Approvals - 1st Quarter of 2024 - PharmaKB Report](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2024q1) [![](https://www.pharmakb.com/hs-fs/hubfs/FDA%20Approved%20PharmaKB%20Report%20Logo-2.png?width=352&name=FDA%20Approved%20PharmaKB%20Report%20Logo-2.png) ](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2023q4) ### [Novel FDA Drug Approvals - 4th Quarter of 2023 - PharmaKB Report](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2023q4) ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "Dr. Yigit Kucuk", "url" : "https://www.pharmakb.com/blog/author/dr-yigit-kucuk" }, "dateModified" : "2024-10-01T18:00:51.172Z", "datePublished" : "2024-10-01T17:57:10.000Z", "headline" : "Novel FDA Drug Approvals - 2nd Quarter of 2024 - PharmaKB Report", "image" : [ "https://www.pharmakb.com/hubfs/FDA%20Approved%20PharmaKB%20Report%20Logo-2.png" ], "mainEntityOfPage" : { "@id" : "https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2024q2", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://www.pharmakb.com/hs-fs/file-17858218-png/images/logo.png" }, "name" : "Collaborative Drug Discovery (CDD), Inc." } } ``` ```json { "@context" : "https://schema.org", "@id" : "https://www.pharmakb.com/#place", "@type" : "Place", "address" : { "@type" : "PostalAddress", "addressCountry" : "United States" } } ``` ```json { "@context" : "https://schema.org", "@id" : "https://www.pharmakb.com/#organization", "@type" : "Organization", "address" : { "@type" : "PostalAddress", "addressCountry" : "United States" }, "location" : { "@id" : "https://www.pharmakb.com/#place" }, "logo" : { "@id" : "https://www.pharmakb.com/#logo", "@type" : "ImageObject", "caption" : "PharmaKB", "height" : "650", "inLanguage" : "en-US", "url" : "https://www.pharmakb.com/hs-fs/hubfs/PharmaKBWhite%20on%20Blue.png?width=2526&name=PharmaKBWhite%20on%20Blue.png", "width" : "650" }, "name" : "PharmaKB", "url" : "https://www.pharmakb.com" } ``` ```json { "@context" : "https://schema.org", "@id" : "https://www.pharmakb.com/#website", "@type" : "WebSite", "inLanguage" : "en-US", "name" : "PharmaKB", "potentialAction" : { "@type" : "SearchAction", "query-input" : "required name=search_term_string", "target" : "https://www.pharmakb.com/search?s={search_term_string}" }, "publisher" : { "@id" : "https://www.pharmakb.com/#organization" }, "url" : "https://www.pharmakb.com" } ``` ```json { "@context" : "https://schema.org", "@id" : "https://www.pharmakb.com/hs-fs/hubfs/PharmaKBWhite%20on%20Blue.png?width=2526&name=PharmaKBWhite%20on%20Blue.png", "@type" : "ImageObject", "caption" : "PharmaKB Logo", "height" : "217", "inLanguage" : "en-US", "url" : "https://www.pharmakb.com/hs-fs/hubfs/PharmaKBWhite%20on%20Blue.png?width=2526&name=PharmaKBWhite%20on%20Blue.png", "width" : "979" } ``` ```json { "@context" : "https://schema.org", "@id" : "https://www.pharmakb.com/#webpage", "@type" : "WebPage", "about" : { "@id" : "https://www.pharmakb.com/#organization" }, "dateModified" : "2022-04-20T10:26:05-07:00", "datePublished" : "2019-07-11T06:43:10-07:00", "inLanguage" : "en-US", "isPartOf" : { "@id" : "https://www.pharmakb.com/#website" }, "name" : "PharmaKB - 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