March 4, 2025 New Treatment Option for ESCC PatientsThe U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr) in…
Browsing: FDA Approved and FDA News
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 TreatmentPublished: February 20, 2025On January 27,…
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, 2025FDA Approves Adcetris OverviewThe FDA has approved a new combination therapy for adults with relapsed or refractory…
FDA Approves Mirdametinib for NF1-PN: A New Option for PatientsIntroduction: The FDA has recently approved Mirdametinib (Gomekli) from SpringWorks Therapeutics…
Date: February 8, 2025The U.S. Food and Drug Administration (FDA) has recently granted approval for datopotamab deruxtecan (DLNK), a new…
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…
IntroductionOn August 2, 2024, the FDA granted accelerated approval to afamitresgene autoleucel (TECELRA) for treating adults with unresectable or metastatic…
On August 1, 2024, the U.S. Food and Drug Administration (FDA) approved an expanded indication for dostarlimab-gxly (Jemperli), in combination…
IntroductionThe US Food and Drug Administration (FDA) recently approved nogapendekin alfa inbakicept-pmln (Anktiva), used in conjunction with bacillus Calmette-Guérin (BCG),…
…The recent approval by the Food and Drug Administration (FDA) of ponatinib (ICLUSIG®) in combination with chemotherapy represents a significant…
OverviewThe U.S. Food and Drug Administration (FDA) has granted approval for the use of inotuzumab ozogamicin (Besponsa, Pfizer) in pediatric…
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…
March 1, 2024 – In a significant advancement for lung cancer treatment, the Food and Drug Administration (FDA) has approved…
On February 15, 2024, the Food and Drug Administration (FDA) approved tepotinib, commercially known as Tepmetko®, for its use in…
Teclistamab FDA approval biweekly dosing in Relapsed or Refractory Multiple Myeloma (3 KOL Video Interviews Below)On February 20th, 2024 the…
What is the new treatment for metastatic melanoma?On February 16, 2024, the medical community witnessed a significant milestone in the…
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…