FDA Backs Lurbinectedin + Atezolizumab for ES-SCLC Care FDA approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals) with atezolizumab (Tecentriq, Genentech) or atezolizumab…
Browsing: FDA Approved and FDA News
Welcome to OncologyTube’s FDA Approval Page! Here, we bring you the latest videos, expert analyses, and updates on FDA-approved oncology treatments and therapies. Dive into detailed discussions, clinical trial highlights, and expert insights on new drug approvals—all tailored for healthcare professionals like you. Stay informed about the most recent advancements in cancer care, straight from the source of regulatory breakthroughs!
Introduction: A New Tool for Breast Cancer Treatment On September 25, 2025, the FDA approved Inluriyo (imlunestrant), an oral selective…
The FDA approved INLEXZO™ / gemcitabine intravesical on September 9, 2025, to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with…
Introduction to Datopotamab Deruxtecan EGFR-Mutated NSCLC On June 23, 2025, the FDA approved Datopotamab Deruxtecan EGFR-Mutated NSCLC treatment, known as…
FDA Voucher Program Oncology: Accelerated Approvals in Oncology On June 17, 2025, the FDA launched the Commissioner’s National Priority Voucher…
On June 11, 2025, the U.S. Food and Drug Administration (FDA) approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a new kinase…
On June 3, 2025, the U.S. Food and Drug Administration (FDA) approved Darolutamide for de novo metastatic castration-sensitive prostate cancer…
FDA approves Penpulimab-kcqx / Anike The FDA approved Anike (Penpulimab-kcqx) on April 23, 2025, for non-keratinizing nasopharyngeal carcinoma (NPC, WHO…
Date: April 8, 2025 On April 8, 2025, the FDA granted regular approval to nivolumab (Opdivo) combined with ipilimumab (Yervoy)…
March 4, 2025 New Treatment Option for ESCC Patients The U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr)…
A Novel Tyrosine Kinase Inhibitor Poised to Transform Advanced Lung Cancer Care Boehringer Ingelheim | Ridgefield, Conn., and Ingelheim, Germany…
FDA Approves Enhertu for HR-Positive, HER2-Low and HER2-Ultralow Breast Cancer: A New Milestone in Treatment Published: February 20, 2025 On…
On February 14, 2025, the U.S. Food and Drug Administration (FDA) delivered a Valentine’s Day gift to patients battling symptomatic…
Date: February 12, 2025 FDA Approves Adcetris Overview The FDA has approved a new combination therapy for adults with relapsed…
FDA Approves Mirdametinib for NF1-PN: A New Option for Patients Introduction: The FDA has recently approved Mirdametinib (Gomekli) from SpringWorks…
Date: February 8, 2025 The U.S. Food and Drug Administration (FDA) has recently granted approval for datopotamab deruxtecan (DLNK), a…
The U.S. Food and Drug Administration (FDA) has recently underscored the significance of understanding Dihydropyrimidine Dehydrogenase (DPD) deficiency in patients…
On January 16, 2025, a significant advancement in cancer treatment was announced. The FDA approved a new therapeutic option for…
The FDA has approved pembrolizumab (Keytruda) combined with platinum-based chemotherapy for the treatment of patients with unresectable, advanced, or metastatic…
The FDA has recently approved Kisqali (ribociclib) in combination with a non-steroidal aromatase inhibitor (NSAI) for the treatment of early-stage…
On September 12, 2024, the U.S. Food and Drug Administration (FDA) approved Tecentriq Hybreza, the first subcutaneous (SC) formulation of…
On August 15, 2024, the U.S. Food and Drug Administration (FDA) approved durvalumab (IMFINZI®, AstraZeneca) in combination with platinum-containing chemotherapy…
Introduction On August 2, 2024, the FDA granted accelerated approval to afamitresgene autoleucel (TECELRA) for treating adults with unresectable or…
On August 1, 2024, the U.S. Food and Drug Administration (FDA) approved an expanded indication for dostarlimab-gxly (Jemperli), in combination…
Introduction The US Food and Drug Administration (FDA) recently approved nogapendekin alfa inbakicept-pmln (Anktiva), used in conjunction with bacillus Calmette-Guérin…
… The recent approval by the Food and Drug Administration (FDA) of ponatinib (ICLUSIG®) in combination with chemotherapy represents a…
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Overview The U.S. Food and Drug Administration (FDA) has granted approval for the use of inotuzumab ozogamicin (Besponsa, Pfizer) in…
On March 7, 2024, the Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib, marketed as Brukinsa by BeiGene…
The FDA granted Priority Review of the supplemental Biologics License Application (sBLA) for epcoritamab-bysp. This subcutaneously administered T-cell engaging bispecific…
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March 1, 2024 – In a significant advancement for lung cancer treatment, the Food and Drug Administration (FDA) has approved…
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On February 15, 2024, the Food and Drug Administration (FDA) approved tepotinib, commercially known as Tepmetko®, for its use in…
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Teclistamab FDA approval biweekly dosing in Relapsed or Refractory Multiple Myeloma (3 KOL Video Interviews Below) On February 20th, 2024…
What is the new treatment for metastatic melanoma? On February 16, 2024, the medical community witnessed a significant milestone in…
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On February 16, 2024, the Food and Drug Administration (FDA) announced the approval of osimertinib, marketed under the brand name…
In the interview, Susan Pandya, MD, Vice President of Clinical Development at Servier Pharmaceuticals, discusses the pivotal FDA acceptance and…
Marwan Fakih, MD – City of Hope – FDA Approval of LONSURF in combination with Bevacizumab The FDA approval of…
The recent approval by the Food and Drug Administration (FDA) of mirvetuximab soravtansine-gynx (Elahere) marks a significant advancement in the…
Molecule, RRx-001, has received fast track designation from the FDA. RRx-001 is a designer molecule with direct anti-inflammatory activity and…
iFrame is not supported! Molecule RRx-001 Receives Fast Track Designation From the FDA – EpicentRx By Tony Reid, MD, PhD,…
Elacestrant: FDA Grants Approval for Breast Cancer Treatment: Insights from Virginia Kaklamani By Virginia Kaklamani So after a patient’s cancer…
iFrame is not supported! Elacestrant: FDA Grants Approval for Breast Cancer Treatment: Insights from Virginia Kaklamani By Virginia Kaklamani So…
Elacestrant: FDA Grants Approval for Breast Cancer Treatment: Insights from Virginia Kaklamani By Virginia Kaklamani So after a patient’s cancer…
iFrame is not supported! Lisocabtagene Maraleucel has been approved by the FDA for the second-line treatment of large B cell…
Breast Density Notification Rule: 2022 FDA: Dense Breasts The FDA Is Updating the Notification Rule For Women With Dense…
Calquence Tablet FDA Approved CLL, SLL, MCL Can You Tell Us The Significance Of The FDA’s Approval Of Calquence? The…
Lisocabtagene Maraleucel has been approved by the FDA for the second-line treatment of large B cell lymphoma LBCL Lisocabtagene Maraleucel…