🗂️ All Events (43 stories)
The U.S. Food and Drug Administration (FDA) 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).
The U.S. Food and Drug Administration (FDA) 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).
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.
Final overall survival results from the EORTC 1333/PEACE-3 trial of enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer are reported. The primary analysis previously demonstrated that the combination improved radiological progression-free survival compared with enzalutamide alone.
Final overall survival results from the EORTC 1333/PEACE-3 trial of enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer are reported. The primary analysis previously demonstrated that the combination improved radiological progression-free survival compared with enzalutami
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
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.
The article describes recent drug approvals for rare diseases. These approvals received communication from CDER or FDA. It is noted that this is not an exhaustive list of all rare disease drug approvals.
The article describes recent drug approvals for rare diseases. These approvals received communication from CDER or FDA. It is noted that this is not an exhaustive list of all rare disease drug approvals.
The FDA has approved Denali Therapeutics’ enzyme replacement therapy for Hunter syndrome, a genetic lysosomal storage disease. This approval marks a significant event, breaking the agency's recent streak of rejections for rare disease treatments.
The FDA has approved Denali Therapeutics’ enzyme replacement therapy for Hunter syndrome, a genetic lysosomal storage disease. This approval marks a significant event, breaking the agency's recent streak of rejections for rare disease treatments.
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.
Insmed has revealed positive Phase 3 trial results for its drug Arikayce. These results could pave the way for a significant label expansion for 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 the treatment of Mycobacterium avium complex (MAC).
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 FDA has approved relacorilant in combination with nab-paclitaxel. This approval is for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The FDA has approved relacorilant in combination with nab-paclitaxel. This approval is for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The U.S. Food and Drug Administration (FDA) approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II). This approval targets the neurologic manifestations of the disease.
The U.S. Food and Drug Administration (FDA) approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II). This approval targets the neurologic manifestations of the disease.
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.
DS-5670d, an omicron XBB.1.5-targeting COVID-19 mRNA vaccine, met its primary endpoint in a Phase 3 non-inferiority study. It demonstrated non-inferior immunogenicity compared to monovalent BNT162b2 omicron XBB.1.5, with an adjusted GMT ratio of 1.218 and an adjusted seroresponse rate difference of 4.5%.
DS-5670d, an omicron XBB.1.5-targeting COVID-19 mRNA vaccine, met its primary endpoint in a Phase 3 non-inferiority study. It demonstrated non-inferior immunogenicity compared to monovalent BNT162b2 omicron XBB.1.5, with an adjusted GMT ratio of 1.218 and an adjusted seroresponse rate difference of
Karyopharm's drug selinexor, in a late-phase trial for myelofibrosis, achieved one co-primary endpoint but failed to meet the other.
Karyopharm's drug selinexor, in a late-phase trial for myelofibrosis, achieved one co-primary endpoint but failed to meet the other.