FDA Approval– tag –
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Oncology Drug Approval News Flash: Daratumumab and hyaluronidase-fihj plus bortezomib, lenalidomide, and dexamethasone approved for newly diagnosed multiple myeloma in transplant-ineligible adults
FDA approval summary On January 27, 2026, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (V... -
Oncology Drug Approval News Flash: FDA grants regular approval to rucaparib for BRCAm mCRPC and approves subcutaneous amivantamab and hyaluronidase-lpuj
FDA approval summary On December 17, 2025, the U.S. Food and Drug Administration (FDA) granted regular approval to rucaparib (Rubraca, pharmaand GmbH) for adult patients with metastatic castration-resistant prostate cancer (mCRPC) associ... -
Oncology Drug Approval News Flash: Fam-trastuzumab deruxtecan-nxki plus pertuzumab approved as first-line therapy for unresectable or metastatic HER2-positive breast cancer
FDA approval summary On December 15, 2025, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults with un... -
Oncology Drug Approval News Flash: Niraparib plus abiraterone acetate and prednisone approved for BRCA2-mutated metastatic castration-sensitive prostate cancer
FDA approval summary On December 12, 2025, the U.S. Food and Drug Administration (FDA) approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adult patients with deleterious or suspected deleteriou... -
Oncology Drug Approval News Flash：FDA approves lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal zone lymphoma
On December 4, 2025, the U.S. Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol Myers Squibb company), a CD19-directed CAR T-cell therapy, for adult patients with relapsed or ref... -
Oncology Drug Approval News Flash：FDA grants traditional approval to pirtobrutinib (Jaypirca) for adults with relapsed or refractory CLL/SLL after covalent BTK inhibitor therapy
On December 3, 2025, the U.S. Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic l... -
Oncology Drug Approval News Flash：FDA approves durvalumab (Imfinzi) plus FLOT as perioperative therapy for resectable gastric and GEJ adenocarcinoma
On November 25, 2025, the U.S. Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by sin... -
Oncology Drug Approval News Flash: FDA approves perioperative pembrolizumab plus enfortumab vedotin-ejfvfor cisplatin-ineligible muscle invasive bladder cancer (MIBC)
On November 21, 2025, the U.S. FDA approved pembrolizumab (Keytruda / Keytruda Qlex) in combination with enfortumab vedotin-ejfv (Padcev) as neoadjuvant and adjuvant therapy for adults with muscle invasive bladder cancer (MIBC) who are e... -
Oncology Drug Approval News Flash: FDA Grants Full Approval to Tarlatamab-dlle for ES-SCLC and Accelerated Approval to Sevabertinib for HER2-Mutated NSCLC
On November 19, 2025, the U.S. Food and Drug Administration (FDA) granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen) for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed after platinum... -
Oncology Drug Approval News Flash: FDA Approves Selumetinib (KOSELUGO) for Adults with Neurofibromatosis Type 1 and Symptomatic, Inoperable Plexiform Neurofibromas
On November 19, 2025, the U.S. Food and Drug Administration (FDA) approved selumetinib (KOSELUGO, AstraZeneca) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). Previously appro... -
Oncology Drug Approval News Flash: FDA Approves Epcoritamab-bysp (Epkinly) with R² for Relapsed or Refractory Follicular Lymphoma
On November 18, 2025, the U.S. Food and Drug Administration (FDA) approved epcoritamab-bysp (Epkinly, Genmab / AbbVie) in combination with lenalidomide and rituximab (R²) for adults with relapsed or refractory follicular lymphoma (FL). T... -
Oncology Drug Approval News Flash: FDA Approves Poherdy (pertuzumab-dpzb) as the First Interchangeable Biosimilar to Perjeta
On November 13, 2025, the U.S. Food and Drug Administration (FDA) approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics) as the first interchangeable biosimilar to Perjeta (pertuzumab, Genentech). This marks a historic step in ex... -
Oncology Drug Approval News Flash: FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma
On November 6, 2025, the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj, Janssen Biotech, Inc.) for the treatment of adults with high-risk smoldering multiple myeloma (SMM). This mark... -
Oncology Drug Approval News Flash: FDA Approves Lurbinectedin Plus Atezolizumab for Maintenance in Extensive-Stage Small Cell Lung Cancer
On October 2, 2025, the U.S. Food and Drug Administration (FDA) approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals) in combination with atezolizumab (Tecentriq, Genentech) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) fo... -
Oncology Drug Approval News Flash: FDA Approves Imlunestrant (Inluriyo) for ER-Positive, HER2-Negative, ESR1-Mutated Breast Cancer
On September 25, 2025, the U.S. Food and Drug Administration (FDA) approved Eli Lilly’s estrogen receptor antagonist Imlunestrant (Inluriyo) for the treatment of adult patients with ER-positive, HER2-negative, ESR1-mutated advanced or me... -
Why Gene & Cell Therapies Stall at the FDA (2024–2025): What Recent CRLs Reveal about CMC, Inspections, and Trial Design
In July 2025, the FDA began publishing past Complete Response Letters (CRLs). Triangulating those releases with company disclosures and primary reporting shows two dominant themes: CMC (quality/manufacturing/testing) & Pre-License In... -
Oncology Drug Approval News Flash: FDA Grants Accelerated Approval to Zongertinib (Hernexeos) for HER2 TKD-Mutated NSCLC
On August 8, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for adults with unresectable or metastatic non-squamo... -
Oncology Drug Approval News Flash: FDA Grants Accelerated Approval to Dordaviprone (Modeyso) for H3 K27M-Mutant Diffuse Midline Glioma
On August 6, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals), a protease activator, for adult and pediatric patients (≥1 year) with progressive H3 K27M-mutant... -
Oncology Drug Approval News Flash: Datopotamab deruxtecan (Datroway) Receives Accelerated FDA Approval for EGFR-mutated NSCLC
[FDA Accelerated Approval] Datroway by Daiichi Sankyo approved for EGFR-mutated non-small cell lung cancer (June 23, 2025) On June 23, 2025, the U.S. FDA granted accelerated approval to Datopotamab deruxtecan-dlnk (Datroway) for adults w... -
Oncology Drug Approval News Flash: Treosulfan (Grafapex) Approved by FDA for Conditioning Prior to allo-HSCT
【FDA Approval Alert】medac's treosulfan (Grafapex) Approved for Conditioning in AML/MDS allo-HSCT (January 21, 2025) On January 21, 2025, the U.S. FDA approved treosulfan (Grafapex) in combination with fludarabine as part of a condition...
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