FDA Approvals

Chris De Savi: FDA Approved 16 Novel Drugs – Here’s My Pick

Chris De Savi/LinkedIn

Aug 11, 2025, 17:13

Chris De Savi: FDA Approved 16 Novel Drugs – Here’s My Pick

Chris De Savi, Chief Scientific Officer, Partner of Curie.Bio, shared a post on LinkedIn:

“Novel FDA Drug Approvals 1H2025

The FDA’s Center for Drug Evaluation and Research (CDER) approved 16 novel drugs in the first half of 2025 — spanning oncology, pain, rare diseases, immunology, and infectious disease prevention.

Here’s the breakdown

Datopotamab deruxtecan (Datroway) – Trop-2-directed mAb + topoisomerase inhibitor ADC for metastatic HR-positive, HER2-negative breast cancer.
Treosulfan (Grafapex) – DNA alkylating agent + fludarabine as a preparative regimen for alloHSCT in AML or MDS.
Suzetrigine (Journavx) – oral Nav1.8 inhibitor, non-opioid analgesic for moderate–severe acute pain.
Mirdametinib (Gomekli) – oral dual MEK1/2 inhibitor for neurofibromatosis type 1.
Vimseltinib (Romvimza) – oral CSF1R kinase inhibitor for symptomatic tenosynovial giant cell tumor.
Gepotidacin (Blujepa) – bacterial DNA gyrase/topoisomerase IV inhibitor for acute cystitis and gonorrhea, incl. MDR strains.
Fitusiran (Qfitlia) – anti-thrombin siRNA (GalNAc-conjugated) for prophylaxis in hemophilia A or B, with or without inhibitors.
Atrasentan (Vanrafia) – endothelin A receptor antagonist to reduce proteinuria in primary IgA nephropathy.
Penpulimab – PD-1 mAb for non-keratinizing nasopharyngeal carcinoma.
Nipocalimab (Imaavy) – FcRn-binding mAb for generalized myasthenia gravis.
Avutometinib/defactinib (Avmapki Fakzynja Co-Pack) – for KRAS-mutated recurrent low-grade serous ovarian cancer.
Telisotuzumab vedotin (Emrelis) – c-Met-directed ADC with microtubule-disrupting payload for NSCLC.
Acoltremon (Tryptyr) – TRPM8 calcium channel activator for dry eye syndrome.
Clesrovimab (Enflonsia) – RSV fusion protein-directed mAb for infant passive immunity.
Taletrectinib (Ibtrozi) – ROS1 / pan-NTRK inhibitor for ROS1-positive NSCLC.
Garadacimab (Andembry) – factor XII-directed mAb for hereditary angioedema prophylaxis.

My Pick – Nipocalimab

Nipocalimab is a human IgG1 monoclonal antibody that targets the neonatal Fc receptor (FcRn), blocking IgG recycling and lowering harmful autoantibodies without affecting IgG production or triggering immune-mediated cytotoxicity.

Approved for generalized myasthenia gravis, it addresses the disease at its source — reducing the antibodies that impair nerve–muscle communication and cause weakness.

This precision approach may pave the way for treating other antibody-driven conditions.”

FDA

More posts featuring Chris De Savi on OncoDaily.

Acoltremon Andembry Atrasentan Avmapki Fakzynja Co-Pack Avutometinib + Defactinib Blujepa cancer CDER Center for Drug Evaluation and Research Chris De Savi Clesrovimab Curie.Bio datopotamab deruxtecan Datroway Emrelis Enflonsia FDA fitusiran Garadacimab Gepotidacin Gomekli GRAFAPEX IBTROZI Imaavy Journavx Mirdametinib nipocalimab OncoDaily Oncology penpulimab Qfitlia Romvimza suzetrigine Taletrectinib Telisotuzumab Vedotin treosulfan Tryptyr Vanrafia vimseltinib

FDA Accepts NDA for Vepdegestrant in ESR1-Mutant ER+/HER2- Advanced Breast Cancer

Hubert Caron Retires from Roche-Genentech

Ramy Sedhom: Palliative Care Isn’t Just about When. It’s about Who, What, and How

Miriam Mutebi: One Small Grant, One Big Difference

Jasmine Kamboj: How We Bring Ourselves to the Table as Leaders