⚡ Top Events Today
Pfizer secures full FDA approval for BRAFTOVI combination in first-line metastatic colorectal cancer
The FDA granted full approval for BRAFTOVI in combination with cetuximab and chemotherapy for adult patients with first-line mCRC harboring a BRAF V600E mutation, based on the Phase 3 BREAKWATER trial.
FDA approves first-of-its-kind device for locally advanced pancreatic cancer
A novel medical device received FDA approval for treating adult patients with locally advanced pancreatic cancer.
Insmed reports positive Phase 3 results for Arikayce, paving way for label expansion
The company announced positive top-line results from a Phase 3 trial of Arikayce for MAC lung disease.
New lung cancer drug Hernexeos approved under FDA's new priority voucher program
The FDA approved Hernexeos for lung cancer as part of the new Commissioner's National Priority Voucher (CNPV) pilot program.
FDA approves teclistamab combination therapy for relapsed or refractory multiple myeloma
The combination of teclistamab and daratumumab hyaluronidase-fihj was approved for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
🗂️ All Events (31 stories)
The U.S. Food and Drug Administration (FDA) has approved a first-of-its-kind device. This device is for the treatment of adult patients with locally advanced pancreatic cancer.
The U.S. Food and Drug Administration (FDA) has approved a first-of-its-kind device. This device is for the treatment of adult patients with locally advanced pancreatic cancer.
The U.S. Food and Drug Administration (FDA) has approved drug labeling changes for six menopausal hormone therapy (HRT) products. These changes are intended to clarify risk considerations for the drugs.
The U.S. Food and Drug Administration (FDA) has approved drug labeling changes for six menopausal hormone therapy (HRT) products. These changes are intended to clarify risk considerations for the drugs.
Pfizer's BRAFTOVI (encorafenib) in combination with cetuximab and fluorouracil-based chemotherapy received full FDA approval for adult patients with first-line metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. This approval is based on results from the global Phase 3 BREAKWATER trial (NCT04607421).
Pfizer's BRAFTOVI (encorafenib) in combination with cetuximab and fluorouracil-based chemotherapy received full FDA approval for adult patients with first-line metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. This approval is based on results from the global Phase 3 BREAKWATER trial (
The U.S. Food and Drug Administration (FDA) today approved the lung cancer drug Hernexeos (zongertinib). This approval was issued as part of the new Commissioner's National Priority Voucher (CNPV) pilot program.
The U.S. Food and Drug Administration (FDA) today approved the lung cancer drug Hernexeos (zongertinib). This approval was issued as part of the new Commissioner's National Priority Voucher (CNPV) pilot program.
The U.S. Food and Drug Administration (FDA) approved teclistamab in combination with daratumumab hyaluronidase-fihj (Tec-Dara) for adult patients with relapsed or refractory multiple myeloma. Patients must have received at least one prior line of therapy. This approval is the third under the National Priority Voucher Program.
The U.S. Food and Drug Administration (FDA) approved teclistamab in combination with daratumumab hyaluronidase-fihj (Tec-Dara) for adult patients with relapsed or refractory multiple myeloma. Patients must have received at least one prior line of therapy. This approval is the third under the Nationa
The U.S. Food and Drug Administration (FDA) has approved the expanded use of Wellcovorin (leucovorin calcium) tablets. This approval is for the treatment of cerebral folate deficiency in adult and pediatric patients with a confirmed variant in the folate receptor 1 gene (CFD-FOLR1). This marks the first treatment approved for this condition.
The U.S. Food and Drug Administration (FDA) has approved the expanded use of Wellcovorin (leucovorin calcium) tablets. This approval is for the treatment of cerebral folate deficiency in adult and pediatric patients with a confirmed variant in the folate receptor 1 gene (CFD-FOLR1). This marks the f
Nature Reviews Drug Discovery published an article on March 17, 2026, announcing upcoming FDA approval decisions. These decisions are anticipated to occur in Q2 2026.
Nature Reviews Drug Discovery published an article on March 17, 2026, announcing upcoming FDA approval decisions. These decisions are anticipated to occur in Q2 2026.
The EORTC 1333/PEACE-3 trial reported final overall survival results for enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer. The primary analysis previously demonstrated that the combination improved radiological progression-free survival compared with enzalutamide alone.
The EORTC 1333/PEACE-3 trial reported final overall survival results for enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer. The primary analysis previously demonstrated that the combination improved radiological progression-free survival compared with enzalutamide alone
Results from a preplanned analysis of the TAXIS/OPBC-03 phase 3 trial were presented by Martin Heidinger at the 2026 Society of Surgical Oncology Annual Meeting. The trial investigated tailored axillary surgery (TAS) for node-positive breast cancer, aiming to reduce morbidity compared to standard axillary lymph node dissection (ALND).
Results from a preplanned analysis of the TAXIS/OPBC-03 phase 3 trial were presented by Martin Heidinger at the 2026 Society of Surgical Oncology Annual Meeting. The trial investigated tailored axillary surgery (TAS) for node-positive breast cancer, aiming to reduce morbidity compared to standard ax
Insmed has revealed positive phase 3 trial results for its drug Arikayce. These results could pave the way for a significant label expansion for Arikayce in the treatment of Mycobacterium avium complex (MAC).
Insmed has revealed positive phase 3 trial results for its drug Arikayce. These results could pave the way for a significant label expansion for Arikayce in the treatment of Mycobacterium avium complex (MAC).
The US Food and Drug Administration (FDA) approved drug labeling changes for 6 menopausal hormone therapy products. These changes were made to clarify risk considerations for the therapies.
The US Food and Drug Administration (FDA) approved drug labeling changes for 6 menopausal hormone therapy products. These changes were made to clarify risk considerations for the therapies.
Dizal has reported positive Phase 3 results for its oral drug Zegfrovy in first-line EGFR exon 20 non-small cell lung cancer. This outcome positions Zegfrovy as a potential competitor to Johnson & Johnson's injectable Rybrevant in the same indication.
Dizal has reported positive Phase 3 results for its oral drug Zegfrovy in first-line EGFR exon 20 non-small cell lung cancer. This outcome positions Zegfrovy as a potential competitor to Johnson & Johnson's injectable Rybrevant in the same indication.
The article describes a listing of accelerated approvals (AAs) for malignant hematology and oncology indications. These approvals are for drugs that have demonstrated verified clinical benefit in postmarketing trials, leading to subsequent traditional approval for the specific indication.
The article describes a listing of accelerated approvals (AAs) for malignant hematology and oncology indications. These approvals are for drugs that have demonstrated verified clinical benefit in postmarketing trials, leading to subsequent traditional approval for the specific indication.
The FDA has approved a supplemental New Drug Application (sNDA) for leucovorin. This approval is for a small patient population, which has raised concerns regarding inconsistent standards and political influence within the FDA.
The FDA has approved a supplemental New Drug Application (sNDA) for leucovorin. This approval is for a small patient population, which has raised concerns regarding inconsistent standards and political influence within the FDA.
The landmark KEYNOTE-522 trial demonstrated improvements in pathological complete response, event-free survival, and overall survival for pembrolizumab in stage II-III triple-negative breast cancer. Despite these advances, global access to immune checkpoint inhibitors is limited by high costs, long infusion times, and serious adverse events, leading to a discussion of low-dose pembrolizumab for more equitable care.
The landmark KEYNOTE-522 trial demonstrated improvements in pathological complete response, event-free survival, and overall survival for pembrolizumab in stage II-III triple-negative breast cancer. Despite these advances, global access to immune checkpoint inhibitors is limited by high costs, long
A blinded, randomised, controlled, phase 3 trial (CAMPASS) demonstrated that benmelstobart plus anlotinib showed longer progression-free survival compared to pembrolizumab plus placebo in PD-L1-positive, advanced non-small-cell lung cancer. No unexpected safety signals were reported, suggesting it as a potential first-line treatment option. Longer term follow-up is needed to establish effects on overall survival.
A blinded, randomised, controlled, phase 3 trial (CAMPASS) demonstrated that benmelstobart plus anlotinib showed longer progression-free survival compared to pembrolizumab plus placebo in PD-L1-positive, advanced non-small-cell lung cancer. No unexpected safety signals were reported, suggesting it a
Karyopharm's drug selinexor achieved one co-primary endpoint but missed the other in a late-phase myelofibrosis trial.
Karyopharm's drug selinexor achieved one co-primary endpoint but missed the other in a late-phase myelofibrosis trial.